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NCT01358877 · CITED IN SOURCE DOCUMENTS

A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2025-11-28

This randomized, double-blind, placebo-controlled, two-arm study will assess the safety and efficacy of pertuzumab in addition to chemotherapy plus trastuzumab as adjuvant therapy in participants with operable HER2-positive primary breast cancer. This study will be carried out in collaboration with the Breast International Group (BIG).

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Excluding SPNBC) at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings

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outcome · POSTED

Percentage of Participants With IDFS Event (Including SPNBC), as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings

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outcome · POSTED

Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Including SPNBC) at 3 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings

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outcome · POSTED

Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Including SPNBC) at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings

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outcome · POSTED

Percentage of Participants With Disease-Free Survival (DFS) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings

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outcome · POSTED

Kaplan-Meier Estimate of the Percentage of Participants Who Were DFS Event-Free at 3 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings

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outcome · POSTED

Kaplan-Meier Estimate of the Percentage of Participants Who Were DFS Event-Free at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings

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outcome · POSTED

Percentage of Participants Who Died, First Interim Overall Survival Analysis

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outcome · POSTED

Percentage of Participants Who Died, Final Overall Survival Analysis

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outcome · POSTED

Kaplan-Meier Estimate of the Percentage of Participants Who Were Alive at 3 Years

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outcome · POSTED

Kaplan-Meier Estimate of the Percentage of Participants Who Were Alive at 6, 8, and 10 Years

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outcome · POSTED

Percentage of Participants With Recurrence-Free Interval (RFI) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings

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outcome · POSTED

Kaplan-Meier Estimate of the Percentage of Participants Who Were RFI Event-Free at 3 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings

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outcome · POSTED

Kaplan-Meier Estimate of the Percentage of Participants Who Were RFI Event-Free at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings

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outcome · POSTED

Percentage of Participants With Distant Recurrence-Free Interval (DRFI) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings

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outcome · POSTED

Kaplan-Meier Estimate of the Percentage of Participants Who Were DRFI Event-Free at 3 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings

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outcome · POSTED

Kaplan-Meier Estimate of the Percentage of Participants Who Were DRFI Event-Free at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings

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outcome · POSTED

Percentage of Participants With Primary Cardiac Event, Primary Analysis

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outcome · POSTED

Percentage of Participants With Primary Cardiac Event, Final Analysis

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outcome · POSTED

Percentage of Participants With Secondary Cardiac Event, Primary Analysis

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outcome · POSTED

Percentage of Participants With Secondary Cardiac Event, Final Analysis

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outcome · POSTED

Change From Baseline in LVEF to Worst Post-Baseline Value, Primary Analysis

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outcome · POSTED

Change From Baseline in LVEF to Worst Post-Baseline Value, Final Analysis

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outcome · POSTED

Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Scale Score

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outcome · POSTED

Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores

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outcome · POSTED

Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores

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outcome · POSTED

Change From Baseline in EORTC QLQ-C30 Financial Difficulties Subscale Scores

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outcome · POSTED

Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score

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outcome · POSTED

Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score

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outcome · POSTED

Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain

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outcome · POSTED

Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain

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outcome · POSTED

Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain

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outcome · POSTED

Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain

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outcome · POSTED

Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain

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outcome · POSTED

Trough Serum Concentration (Cmin) of Pertuzumab

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outcome · POSTED

Cmin of Trastuzumab

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outcome · POSTED

Peak Serum Concentration (Cmax) of Pertuzumab

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outcome · POSTED

Cmax of Trastuzumab

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outcome · POSTED

Percentage of Participants With Invasive Disease-Free Survival (IDFS) Event (Excluding Second Primary Non-Breast Cancer [SPNBC]), as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings

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outcome · POSTED

Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Excluding SPNBC) at 3 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * Non-metastatic operable primary invasive HER2-positive carcinoma of the breast that is histologically confirmed, and adequately excised * Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (\</=) 1 * Known hormone receptor status (estrogen receptor and progesterone receptor) * The interval between definitive surgery for breast cancer and the first dose of chemotherapy must be no more than 8 weeks (56 days). The first cycle of chemotherapy must be administered within 7 days of randomization or on Day 56, whichever occurs first * Baseline left ventricular ejection fraction (LVEF) greater than or equal to (\>/=) 55 percent (%) measured by echocardiogram (ECHO) or Multiple-Gated Acquisition (MUGA) Scan * Confirmed HER2 positive status * Completion of all necessary baseline laboratory and radiologic investigations prior to randomization * Women of childbearing potential and male participants with partners of childbearing potential must agree to use effective contraception (as defined by the protocol) by the participant and/or partner for the duration of the study treatment and for at least 7 months after the last dose of study drug Exclusion Criteria: * History of any prior (ipsi- and/or contralateral) invasive breast cancer * History of non-breast malignancies within the 5 years prior to study entry, except for carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinomas of the skin * Any "clinical" T4 tumor as defined by primary tumor/regional lymph nodes/distant metastasis (TNM), including inflammatory breast cancer * Any node-negative tumor * Any previous systemic chemotherapy for cancer or radiotherapy for cancer * Prior use of anti-HER2 therapy for any reason or other prior biologic or immunotherapy for cancer * Concurrent anti-cancer treatment in another investigational trial * Serious cardiac or cardiovascular disease or condition * Other concurrent serious diseases that may interfere with planned treatment including severe pulmonary conditions/illness * Abnormal laboratory tests immediately prior to randomization * Pregnant or lactating women * Sensitivity to any of the study medications or any of the ingredients or excipients of these medications
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Participants will receive pertuzumab (840 mg loading dose, then 420 mg) and trastuzumab (8 mg/kg loading dose, then 6 mg/kg) intravenously (IV) every 3 weeks (Q3W) for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 mg/m\^2 + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 once weekly (QW); 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin area under the curve (AUC) 6 (up to 900 mg).
    intervention Names
    1. Drug: 5-Fluorouracil
    2. Drug: Carboplatin
    3. Drug: Cyclophosphamide
    4. Drug: Docetaxel
    5. Drug: Doxorubicin
    6. Drug: Epirubicin
    7. Drug: Paclitaxel
    8. Drug: Pertuzumab
    9. Drug: Trastuzumab
    label
    Pertuzumab + Trastuzumab + Chemotherapy
    type
    EXPERIMENTAL
  2. description
    Participants will receive placebo matching to pertuzumab IV Q3W and trastuzumab (8 milligrams per kilogram \[mg/kg\] loading dose, then 6 mg/kg) IV Q3W for 1 year (maximum 18 cycles) in combination with 1 of the following IV chemotherapy regimen (anthracycline-based or nonanthracycline-based) per Investigator's choice: 1) 3-4 cycles (Q3W) of 5-fluorouracil 500-600 milligrams per square meter (mg/m\^2) + epirubicin 90-120 mg/m\^2 or doxorubicin 50 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W (100 mg/m\^2 for 3 cycles, 75 mg/m\^2 in first cycle and 100 mg/m\^2 in subsequent cycles, or 75 mg/m\^2 for 4 cycles) or 12 cycles of paclitaxel 80 mg/m\^2 QW; 2) 4 cycles (Q3W) of doxorubicin 60 mg/m\^2 or epirubicin 90-120 mg/m\^2 + cyclophosphamide 500-600 mg/m\^2 followed by either 3-4 cycles of docetaxel Q3W or 12 cycles of paclitaxel QW (as described in Option 1); 3) 6 cycles (Q3W) of docetaxel 75 mg/m\^2 + carboplatin AUC 6 (up to 900 milligrams \[mg\]).
    intervention Names
    1. Drug: 5-Fluorouracil
    2. Drug: Carboplatin
    3. Drug: Cyclophosphamide
    4. Drug: Docetaxel
    5. Drug: Doxorubicin
    6. Drug: Epirubicin
    7. Drug: Paclitaxel
    8. Drug: Placebo
    9. Drug: Trastuzumab
    label
    Placebo + Trastuzumab + Chemotherapy
    type
    PLACEBO_COMPARATOR
interventions
  1. arm Group Labels
    1. Pertuzumab + Trastuzumab + Chemotherapy
    2. Placebo + Trastuzumab + Chemotherapy
    description
    5-Fluorouracil will be administered as per the schedule specified in the respective arm.
    name
    5-Fluorouracil
    type
    DRUG
  2. arm Group Labels
    1. Pertuzumab + Trastuzumab + Chemotherapy
    2. Placebo + Trastuzumab + Chemotherapy
    description
    Carboplatin will be administered as per the schedule specified in the respective arm.
    name
    Carboplatin
    type
    DRUG
  3. arm Group Labels
    1. Pertuzumab + Trastuzumab + Chemotherapy
    2. Placebo + Trastuzumab + Chemotherapy
    description
    Cyclophosphamide will be administered as per the schedule specified in the respective arm.
    name
    Cyclophosphamide
    type
    DRUG
  4. arm Group Labels
    1. Pertuzumab + Trastuzumab + Chemotherapy
    2. Placebo + Trastuzumab + Chemotherapy
    description
    Docetaxel will be administered as per the schedule specified in the respective arm.
    name
    Docetaxel
    type
    DRUG
  5. arm Group Labels
    1. Pertuzumab + Trastuzumab + Chemotherapy
    2. Placebo + Trastuzumab + Chemotherapy
    description
    Doxorubicin will be administered as per the schedule specified in the respective arm.
    name
    Doxorubicin
    type
    DRUG
  6. arm Group Labels
    1. Pertuzumab + Trastuzumab + Chemotherapy
    2. Placebo + Trastuzumab + Chemotherapy
    description
    Epirubicin will be administered as per the schedule specified in the respective arm.
    name
    Epirubicin
    type
    DRUG
  7. arm Group Labels
    1. Pertuzumab + Trastuzumab + Chemotherapy
    2. Placebo + Trastuzumab + Chemotherapy
    description
    Paclitaxel will be administered as per the schedule specified in the respective arm.
    name
    Paclitaxel
    type
    DRUG
  8. arm Group Labels
    1. Pertuzumab + Trastuzumab + Chemotherapy
    description
    Pertuzumab will be administered as per the schedule specified in the respective arm.
    name
    Pertuzumab
    other Names
    1. Perjeta®
    type
    DRUG
  9. arm Group Labels
    1. Placebo + Trastuzumab + Chemotherapy
    description
    Placebo will be administered as per the schedule specified in the respective arm.
    name
    Placebo
    type
    DRUG
  10. arm Group Labels
    1. Pertuzumab + Trastuzumab + Chemotherapy
    2. Placebo + Trastuzumab + Chemotherapy
    description
    Trastuzumab will be administered as per the schedule specified in the respective arm.
    name
    Trastuzumab
    other Names
    1. Herceptin®
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
DOUBLE
who Masked
  1. PARTICIPANT
  2. INVESTIGATOR
primary Purpose
TREATMENT
Enrollment
count
4804
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Percentage of participants with IDFS events (excluding SPNBC) is reported. IDFS event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (that is \[i.e.\], an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer. All SPNBCs and in situ carcinomas (including ductal carcinoma in situ \[DCIS\] and lobular carcinoma in situ \[LCIS\]) and non-melanoma skin cancer were excluded as an event.
    measure
    Percentage of Participants With Invasive Disease-Free Survival (IDFS) Event (Excluding Second Primary Non-Breast Cancer [SPNBC]), as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
    time Frame
    Randomization to the first occurrence of IDFS event (excluding SPNBC) (until data cut-off date 19 December 2016; median [range] follow-up: 3.8 [0-4.9] years)
  2. description
    Kaplan-Meier estimate of the percentage of participants who were IDFS event-free (excluding SPNBC) at 3 years is reported. IDFS event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer. All SPNBCs and in situ carcinomas (including DCIS and LCIS) and non-melanoma skin cancer were excluded as an event.
    measure
    Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Excluding SPNBC) at 3 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
    time Frame
    3 years
secondary Outcomes
  1. description
    The Kaplan-Meier estimates of the percentage of participants who were IDFS event-free (excluding SPNBC) at 6, 8, and 10 years are reported. IDFS event was defined as the first occurrence of one of the following events: ipsilateral invasive breast tumor recurrence, ipsilateral local-regional invasive breast cancer recurrence, distant recurrence, death attributable to any cause, or contralateral invasive breast cancer. All SPNBCs and in situ carcinomas (including DCIS and LCIS) and non-melanoma skin cancer were excluded as an event. Participants who had not had an event at the time of data analysis were censored at the date last known to be alive and event-free.
    measure
    Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Excluding SPNBC) at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
    time Frame
    6, 8, and 10 years
  2. description
    Percentage of participants with IDFS events (including SPNBC) is reported. IDFS-SPNBC event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC (with the exception of non-melanoma skin cancers and in situ carcinoma of any site).
    measure
    Percentage of Participants With IDFS Event (Including SPNBC), as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
    time Frame
    Randomization to the first occurrence of IDFS event (including SPNBC) (until data cut-off date 19 December 2016; median [range] follow-up: 3.8 [0-4.9] years)
  3. description
    Kaplan-Meier estimate of the percentage of participants who were IDFS event-free (including SPNBC) at 3 years is reported. IDFS-SPNBC was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC (with the exception of non-melanoma skin cancers and in situ carcinoma of any site).
    measure
    Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Including SPNBC) at 3 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
    time Frame
    3 years
  4. description
    Kaplan-Meier estimates of the percentage of participants who were IDFS event-free (including SPNBC) at 6, 8, and 10 years are reported. IDFS-SPNBC was defined as the first occurrence of one of the following events: ipsilateral invasive breast tumor recurrence, ipsilateral local-regional invasive breast cancer recurrence, distant recurrence, death attributable to any cause, contralateral invasive breast cancer, or SPNBC (with the exception of non-melanoma skin cancers and in situ carcinoma of any site). Participants who had not had an event at the time of data analysis were censored at the date last known to be alive and event-free.
    measure
    Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Including SPNBC) at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
    time Frame
    6, 8, and 10 years
  5. description
    Percentage of participants with DFS event is reported. DFS event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC or contralateral or ipsilateral DCIS.
    measure
    Percentage of Participants With Disease-Free Survival (DFS) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
    time Frame
    Randomization to the first occurrence of DFS event (until data cut-off date 19 December 2016; median [range] follow-up: 3.8 [0-4.9] years)
  6. description
    Kaplan-Meier estimate of the percentage of participants who were DFS event-free at 3 years is reported. DFS was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site - other than the two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC or contralateral or ipsilateral DCIS.
    measure
    Kaplan-Meier Estimate of the Percentage of Participants Who Were DFS Event-Free at 3 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
    time Frame
    3 years
  7. description
    Kaplan-Meier estimates of the percentage of participants who were DFS event-free at 6, 8, and 10 years are reported. DFS was defined as the first occurrence of one of the following events: ipsilateral invasive breast tumor recurrence, ipsilateral local-regional invasive breast cancer recurrence, distant recurrence, death attributable to any cause, contralateral invasive breast cancer, SPNBC, or contralateral or ipsilateral DCIS. Participants who had not had an event at the time of data analysis were censored at the date last known to be alive and event-free.
    measure
    Kaplan-Meier Estimate of the Percentage of Participants Who Were DFS Event-Free at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
    time Frame
    6, 8, and 10 years
  8. description
    Percentage of participants who died due to any cause is reported.
    measure
    Percentage of Participants Who Died, First Interim Overall Survival Analysis
    time Frame
    Randomization until death due to any cause (until data cut-off date 19 December 2016; median [range] follow-up: 3.8 [0-4.9] years)
  9. description
    Percentage of participants who died due to any cause is reported.
    measure
    Percentage of Participants Who Died, Final Overall Survival Analysis
    time Frame
    Randomization until death due to any cause (median [range] follow-up: 11.3 [0-12.9] years)
  10. description
    The Kaplan-Meier approach was used to estimate the percentage of participants who were alive at 3 years. Participants who were alive (including lost to follow-up) at the time of the analysis were censored at the date when they were last known to be alive.
    measure
    Kaplan-Meier Estimate of the Percentage of Participants Who Were Alive at 3 Years
    time Frame
    3 years
  11. description
    The Kaplan-Meier approach was used to estimate the percentage of participants who were alive at 6, 8, and 10 years. Participants who were alive (including lost to follow-up) at the time of the analysis were censored at the date when they were last known to be alive.
    measure
    Kaplan-Meier Estimate of the Percentage of Participants Who Were Alive at 6, 8, and 10 Years
    time Frame
    6, 8, and 10 years
  12. description
    Percentage of participants with RFI event is reported. RFI event was defined as local, regional or distant breast cancer recurrence.
    measure
    Percentage of Participants With Recurrence-Free Interval (RFI) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
    time Frame
    Randomization until local, regional or distant breast cancer recurrence (until data cut-off date 19 December 2016; median [range] follow-up: 3.8 [0-4.9] years)
Full study description
brief Summary
This randomized, double-blind, placebo-controlled, two-arm study will assess the safety and efficacy of pertuzumab in addition to chemotherapy plus trastuzumab as adjuvant therapy in participants with operable HER2-positive primary breast cancer. This study will be carried out in collaboration with the Breast International Group (BIG).
Source references
references
  1. citation
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    pmid
    41934626
    type
    DERIVED
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    pmid
    39259927
    type
    DERIVED
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    pmid
    36681013
    type
    DERIVED
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    pmid
    35512402
    type
    DERIVED
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    pmid
    35313167
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  6. citation
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    pmid
    33828257
    type
    DERIVED
  7. citation
    Piccart M, Procter M, Fumagalli D, de Azambuja E, Clark E, Ewer MS, Restuccia E, Jerusalem G, Dent S, Reaby L, Bonnefoi H, Krop I, Liu TW, Pienkowski T, Toi M, Wilcken N, Andersson M, Im YH, Tseng LM, Lueck HJ, Colleoni M, Monturus E, Sicoe M, Guillaume S, Bines J, Gelber RD, Viale G, Thomssen C; APHINITY Steering Committee and Investigators. Adjuvant Pertuzumab and Trastuzumab in Early HER2-Positive Breast Cancer in the APHINITY Trial: 6 Years' Follow-Up. J Clin Oncol. 2021 May 1;39(13):1448-1457. doi: 10.1200/JCO.20.01204. Epub 2021 Feb 4.
    pmid
    33539215
    type
    DERIVED
  8. citation
    Bines J, Procter M, Restuccia E, Viale G, Zardavas D, Suter T, Arahmani A, Van Dooren V, Baselga J, Clark E, Eng-Wong J, Gelber RD, Piccart M, Mobus V, de Azambuja E; APHINITY Steering Committee and Investigators. Incidence and Management of Diarrhea With Adjuvant Pertuzumab and Trastuzumab in Patients With Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer. Clin Breast Cancer. 2020 Apr;20(2):174-181.e3. doi: 10.1016/j.clbc.2019.06.016. Epub 2019 Sep 5.
    pmid
    31924513
    type
    DERIVED
  9. citation
    Luo Y, Li W, Jiang Z, Zhang Q, Wang L, Mao Y, Tjan-Heijnen VCG, Im SA, McConnell R, Bejarano S, Fumagalli D, Bines J, Wang B, Garg A, Kirschbrown WP, Xu B. Pharmacokinetics of pertuzumab administered concurrently with trastuzumab in Chinese patients with HER2-positive early breast cancer. Anticancer Drugs. 2019 Sep;30(8):866-872. doi: 10.1097/CAD.0000000000000808.
    pmid
    31305270
    type
    DERIVED
  10. citation
    Kirschbrown WP, Kagedal M, Wang B, Lindbom L, Knott A, Mack R, Monemi S, Nijem I, Girish S, Freeman C, Fumagalli D, McConnell R, Jerusalem G, Twelves C, Baselga J, von Minckwitz G, Bines J, Garg A. Pharmacokinetic and exploratory exposure-response analysis of pertuzumab in patients with operable HER2-positive early breast cancer in the APHINITY study. Cancer Chemother Pharmacol. 2019 Jun;83(6):1147-1158. doi: 10.1007/s00280-019-03826-1. Epub 2019 Apr 11.
    pmid
    30976844
    type
    DERIVED
  11. citation
    von Minckwitz G, Procter M, de Azambuja E, Zardavas D, Benyunes M, Viale G, Suter T, Arahmani A, Rouchet N, Clark E, Knott A, Lang I, Levy C, Yardley DA, Bines J, Gelber RD, Piccart M, Baselga J; APHINITY Steering Committee and Investigators. Adjuvant Pertuzumab and Trastuzumab in Early HER2-Positive Breast Cancer. N Engl J Med. 2017 Jul 13;377(2):122-131. doi: 10.1056/NEJMoa1703643. Epub 2017 Jun 5.
    pmid
    28581356
    type
    DERIVED
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        venous trastuzumab administered in combination with chemotherapy in adults with HER2-overexpressing early breast cancer (NCT00545688, NCT00976989, NCT02132949, NCT01358877) and additional pharmacokinetic and safety data that demonstrated comparable pharmacokinetics and safety profiles between PHESGO and intravenous pertuzumab and
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        tabindex="-1">The FDA approval of pertuzumab was subsequently converted to regular approval following the results of the confirmatory <a href="/clinicaltrials/NCT01358877">APHINITY</a> trial (NCT01358877), a randomized, phase III, adjuvant study for women with HER2-positive breast cancer. Study results demonstrated improved IDFS
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        f pertuzumab was subsequently converted to regular approval following the results of the confirmatory <a href="/clinicaltrials/NCT01358877">APHINITY</a> trial (NCT01358877), a randomized, phase III, adjuvant study for women with HER2-positive breast cancer. Study results demonstrated improved IDFS with the combination of chemothe
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        Updated: April 25, 2025
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    Preserved source evidence · Not medical advice