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).
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What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
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
Percentage of Participants With IDFS Event (Including SPNBC), as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
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
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
Percentage of Participants With Disease-Free Survival (DFS) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
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
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
Percentage of Participants Who Died, First Interim Overall Survival Analysis
Percentage of Participants Who Died, Final Overall Survival Analysis
Kaplan-Meier Estimate of the Percentage of Participants Who Were Alive at 3 Years
Kaplan-Meier Estimate of the Percentage of Participants Who Were Alive at 6, 8, and 10 Years
Percentage of Participants With Recurrence-Free Interval (RFI) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
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
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
Percentage of Participants With Distant Recurrence-Free Interval (DRFI) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
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
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
Percentage of Participants With Primary Cardiac Event, Primary Analysis
Percentage of Participants With Primary Cardiac Event, Final Analysis
Percentage of Participants With Secondary Cardiac Event, Primary Analysis
Percentage of Participants With Secondary Cardiac Event, Final Analysis
Change From Baseline in LVEF to Worst Post-Baseline Value, Primary Analysis
Change From Baseline in LVEF to Worst Post-Baseline Value, Final Analysis
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
Change From Baseline in EORTC QLQ-C30 Functioning Subscale Scores
Change From Baseline in EORTC QLQ-C30 Disease/Treatment-Related Symptoms Subscale Scores
Change From Baseline in EORTC QLQ-C30 Financial Difficulties Subscale Scores
Change From Baseline in European Organisation for Research and Treatment of Cancer - Breast Cancer Module Quality of Life (EORTC QLQ-BR23) Functional Scale Score
Change From Baseline in EORTC QLQ-BR23 Symptom Scale Score
Percentage of Participants With Response for European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Questionnaire: Mobility Domain
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Self-Care Domain
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Usual Activities Domain
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Pain/Discomfort Domain
Percentage of Participants With Response for EQ-5D-3L Questionnaire: Anxiety/Depression Domain
Trough Serum Concentration (Cmin) of Pertuzumab
Cmin of Trastuzumab
Peak Serum Concentration (Cmax) of Pertuzumab
Cmax of Trastuzumab
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
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
Adverse events
Limitations, agreements, and source contact
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
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- 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
- Drug: 5-Fluorouracil
- Drug: Carboplatin
- Drug: Cyclophosphamide
- Drug: Docetaxel
- Drug: Doxorubicin
- Drug: Epirubicin
- Drug: Paclitaxel
- Drug: Pertuzumab
- Drug: Trastuzumab
- label
- Pertuzumab + Trastuzumab + Chemotherapy
- type
- EXPERIMENTAL
- 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
- Drug: 5-Fluorouracil
- Drug: Carboplatin
- Drug: Cyclophosphamide
- Drug: Docetaxel
- Drug: Doxorubicin
- Drug: Epirubicin
- Drug: Paclitaxel
- Drug: Placebo
- Drug: Trastuzumab
- label
- Placebo + Trastuzumab + Chemotherapy
- type
- PLACEBO_COMPARATOR
- interventions
- arm Group Labels
- Pertuzumab + Trastuzumab + Chemotherapy
- Placebo + Trastuzumab + Chemotherapy
- description
- 5-Fluorouracil will be administered as per the schedule specified in the respective arm.
- name
- 5-Fluorouracil
- type
- DRUG
- arm Group Labels
- Pertuzumab + Trastuzumab + Chemotherapy
- Placebo + Trastuzumab + Chemotherapy
- description
- Carboplatin will be administered as per the schedule specified in the respective arm.
- name
- Carboplatin
- type
- DRUG
- arm Group Labels
- Pertuzumab + Trastuzumab + Chemotherapy
- Placebo + Trastuzumab + Chemotherapy
- description
- Cyclophosphamide will be administered as per the schedule specified in the respective arm.
- name
- Cyclophosphamide
- type
- DRUG
- arm Group Labels
- Pertuzumab + Trastuzumab + Chemotherapy
- Placebo + Trastuzumab + Chemotherapy
- description
- Docetaxel will be administered as per the schedule specified in the respective arm.
- name
- Docetaxel
- type
- DRUG
- arm Group Labels
- Pertuzumab + Trastuzumab + Chemotherapy
- Placebo + Trastuzumab + Chemotherapy
- description
- Doxorubicin will be administered as per the schedule specified in the respective arm.
- name
- Doxorubicin
- type
- DRUG
- arm Group Labels
- Pertuzumab + Trastuzumab + Chemotherapy
- Placebo + Trastuzumab + Chemotherapy
- description
- Epirubicin will be administered as per the schedule specified in the respective arm.
- name
- Epirubicin
- type
- DRUG
- arm Group Labels
- Pertuzumab + Trastuzumab + Chemotherapy
- Placebo + Trastuzumab + Chemotherapy
- description
- Paclitaxel will be administered as per the schedule specified in the respective arm.
- name
- Paclitaxel
- type
- DRUG
- arm Group Labels
- Pertuzumab + Trastuzumab + Chemotherapy
- description
- Pertuzumab will be administered as per the schedule specified in the respective arm.
- name
- Pertuzumab
- other Names
- Perjeta®
- type
- DRUG
- arm Group Labels
- Placebo + Trastuzumab + Chemotherapy
- description
- Placebo will be administered as per the schedule specified in the respective arm.
- name
- Placebo
- type
- DRUG
- arm Group Labels
- Pertuzumab + Trastuzumab + Chemotherapy
- Placebo + Trastuzumab + Chemotherapy
- description
- Trastuzumab will be administered as per the schedule specified in the respective arm.
- name
- Trastuzumab
- other Names
- Herceptin®
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- DOUBLE
- who Masked
- PARTICIPANT
- INVESTIGATOR
- primary Purpose
- TREATMENT
Enrollment
- count
- 4804
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- 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)
- 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
- 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
- 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)
- 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
- 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
- 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)
- 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
- 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
- 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)
- 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)
- 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
- 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
- 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).
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- DERIVED
- citation
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- 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.
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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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- Updated: April 25, 2025
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Preserved source evidence · Not medical advice
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