Skip to content
Triangle logo TriangleGet started
← Study library

NCT03498716 · CITED IN SOURCE DOCUMENTS

A Study Comparing Atezolizumab (Anti PD-L1 Antibody) In Combination With Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone In Patients With Operable Triple-Negative 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
TERMINATED
Registry last update
2024-08-21

This study will evaluate the efficacy, safety, and pharmacokinetics of adjuvant atezolizumab in combination with paclitaxel, followed by atezolizumab, dose-dense doxorubicin or epirubicin (investigator's choice), and cyclophosphamide, compared with paclitaxel followed by dose-dense doxorubicin or epirubicin (investigator's choice) and cyclophosphamide alone in patients with Stage II-III TNBC (Triple Negative Breast Cancer)

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

→

baseline

Baseline characteristics

→

outcome · POSTED

Invasive Disease-Free Survival (iDFS)

→

outcome · POSTED

Invasive Disease-Free Survival (iDFS) in the Subpopulation With Programmed Death-ligand 1 (PD-L1) Selected Tumor Status (IC1/2/3)

→

outcome · POSTED

Invasive Disease-Free Survival (iDFS) in the Node Positive Subpopulation

→

outcome · POSTED

Overall Survival (OS)

→

outcome · POSTED

Invasive Disease-Free Survival (iDFS) Including Second Primary Non-Breast Invasive Cancer

→

outcome · POSTED

Recurrence-Free Interval (RFI)

→

outcome · POSTED

Distant Recurrence-Free Interval (DRFI)

→

outcome · POSTED

Disease-Free Survival (DFS)

→

outcome · POSTED

Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Patient-reported Function (Role Functioning [Q6, Q7])

→

outcome · POSTED

Change From Baseline in EORTC QLQ-C30 Patient-reported Function (Physical Functioning [Q1-Q5])

→

outcome · POSTED

Change From Baseline in EORTC QLQ-C30 Global Health Status (GHS) [Q29] and Health-Related Quality of Life (HRQoL) [Q30] Combined Score

→

outcome · POSTED

Number of Participants With Adverse Events (AE)

→

outcome · POSTED

Serum Concentration of Atezolizumab

→

outcome · POSTED

Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→
Who could take part
eligibility Criteria
Inclusion Criteria: * Non-metastatic operable Stage II-III breast cancer * Histologically documented TNBC (Triple Negative Breast Cancer) * Confirmed tumor PD-L1 evaluation as documented through central testing of a representative tumor tissue specimen * Adequately excised: Patients must have undergone either breast-conserving surgery or mastectomy/nipple- or skin-sparing mastectomy * Adequate hematologic and end-organ function * For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures * For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm. * No more than 8 weeks (56 days) may elapse between definitive breast surgery and randomization. * Representative formalin-fixed, paraffin embedded (FFPE) tumor specimen from surgical resection in paraffin blocks (preferred) or at least 25 unstained slides. Exclusion Criteria * Prior history of invasive breast cancer * For the currently diagnosed breast cancer, any previous systemic anti-cancer treatment (e.g., neoadjuvant or adjuvant), including, but not limited to, chemotherapy, anti-HER2 therapy. * Previous therapy with anthracyclines or taxanes for any malignancy * Cardiopulmonary dysfunction * Prior malignancies within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome * Active or history of autoimmune disease or immune deficiency * History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan * Urinary outflow obstruction * Active tuberculosis * Major surgical procedure other than for diagnosis within 4 weeks prior to initiation of study treatment or anticipation of need for a major surgical procedure during study treatment or within 5 months following the last dose of Atezolizumab (for patients randomized to Atezolizumab) * Prior allogeneic stem cell or solid organ transplant * Treatment with systemic immunosuppressive medications within 2 weeks prior to initiation of study treatment or anticipation of need for systemic immunosuppressive medication during the study
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 atezolizumab (in combination with chemotherapy as described below) every 2 weeks for 10 doses, followed by atezolizumab maintenance therapy every 3 weeks to complete 1 year of treatment from the first dose Chemotherapy will consist of paclitaxel every week for 12 weeks, followed by dose-dense doxorubicin +cyclophosphamide or dose-dense epirubicin + cyclophosphamide every 2 weeks, for 4 doses supported with Granulocyte Colony-Stimulating Factor (G-CSF) or Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF)
    intervention Names
    1. Drug: Atezolizumab
    2. Drug: Paclitaxel
    3. Drug: Dose-dense Doxorubicin or dose-dense Epirubicin
    4. Drug: Cyclophosphamide
    label
    Atezolizumab + Chemotherapy
    type
    EXPERIMENTAL
  2. description
    Chemotherapy will consist of paclitaxel every week for 12 weeks, followed by dose-dense doxorubicin +cyclophosphamide or dose-dense epirubicin + cyclophosphamide every 2 weeks, for 4 doses supported with Granulocyte Colony-Stimulating Factor (G-CSF) or Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF)
    intervention Names
    1. Drug: Paclitaxel
    2. Drug: Dose-dense Doxorubicin or dose-dense Epirubicin
    3. Drug: Cyclophosphamide
    label
    Chemotherapy
    type
    ACTIVE_COMPARATOR
interventions
  1. arm Group Labels
    1. Atezolizumab + Chemotherapy
    description
    Atezolizumab will be administered by IV, 840 mg every 2 weeks, for 10 doses. Atezolizumab maintenance will be administered by IV, 1200 mg every 3 weeks to complete 1 year
    name
    Atezolizumab
    type
    DRUG
  2. arm Group Labels
    1. Atezolizumab + Chemotherapy
    2. Chemotherapy
    description
    Paclitaxel will be administered by IV, 80 mg/m\^2 every week for 12 weeks.
    name
    Paclitaxel
    type
    DRUG
  3. arm Group Labels
    1. Atezolizumab + Chemotherapy
    2. Chemotherapy
    description
    Dose-dense doxorubicin will be administered by IV, 60 mg/m\^2 every 2 weeks for a total of 4 doses. Or Dose-dense epirubicin will be administered by IV, (90 mg/m\^2) every 2 weeks for a total of 4 doses
    name
    Dose-dense Doxorubicin or dose-dense Epirubicin
    type
    DRUG
  4. arm Group Labels
    1. Atezolizumab + Chemotherapy
    2. Chemotherapy
    description
    Cyclophosphamide will be administered by IV, 600 mg/m\^2 every 2 weeks for 4 doses
    name
    Cyclophosphamide
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
2199
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    iDFS was defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (an invasive breast cancer involving the same breast parenchyma as the original primary lesion); Ipsilateral local-regional invasive breast cancer recurrence (an invasive breast cancer in the axilla, regional lymph nodes, chest wall, \&/or skin of the ipsilateral breast); Ipsilateral second primary invasive breast cancer; Contralateral invasive breast cancer; Distant recurrence (evidence of breast cancer in any anatomic site \[other than the sites mentioned\]) that has either been histologically confirmed \&/or clinically/radiographically diagnosed as recurrent invasive breast cancer; \& Death attributable to any cause, including breast cancer, non-breast cancer, or unknown cause. Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis or no post-baseline information were censored.
    measure
    Invasive Disease-Free Survival (iDFS)
    time Frame
    From randomization until the occurrence of an iDFS event or death from any cause, whichever occurred earlier (up to 5 years)
secondary Outcomes
  1. description
    iDFS = the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (an invasive breast cancer involving the same breast parenchyma as the original primary lesion); Ipsilateral local-regional invasive breast cancer recurrence (an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); Ipsilateral second primary invasive breast cancer, Contralateral invasive breast cancer, Distant recurrence (i.e., evidence of breast cancer in any anatomic site \[other than the sites mentioned\]) that has either been histologically confirmed and/or clinically/radiographically diagnosed as recurrent invasive breast cancer and Death attributable to any cause, including breast cancer, non-breast cancer, or unknown cause. Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis or no post-baseline information were censored.
    measure
    Invasive Disease-Free Survival (iDFS) in the Subpopulation With Programmed Death-ligand 1 (PD-L1) Selected Tumor Status (IC1/2/3)
    time Frame
    From randomization until the occurrence of an iDFS event or death from any cause, whichever occurred earlier (up to 5 years)
  2. description
    iDFS = the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (an invasive breast cancer involving the same breast parenchyma as the original primary lesion); Ipsilateral local-regional invasive breast cancer recurrence (an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); Ipsilateral second primary invasive breast cancer; Contralateral invasive breast cancer; Distant recurrence (evidence of breast cancer in any anatomic site \[other than the sites mentioned\]) that has either been histologically confirmed and/or clinically/radiographically diagnosed as recurrent invasive breast cancer; and Death attributable to any cause, including breast cancer, non-breast cancer, or unknown cause. Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis or no post-baseline information were censored.
    measure
    Invasive Disease-Free Survival (iDFS) in the Node Positive Subpopulation
    time Frame
    From randomization until the occurrence of an iDFS event or death from any cause, whichever occurred earlier (up to 5 years)
  3. description
    Overall Survival (OS) is defined as the time from randomization to the date of death due to any cause. Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis or no post-baseline information were censored.
    measure
    Overall Survival (OS)
    time Frame
    From randomization up to death from any cause (up to 5 years)
  4. description
    iDFS = the time from randomization until the date of first occurrence of one of the events: Ipsilateral invasive breast tumor recurrence (an invasive breast cancer involving same breast parenchyma as the original primary lesion); Ipsilateral local-regional invasive breast cancer recurrence (an invasive breast cancer in axilla, regional lymph nodes, chest wall, \&/or skin of the ipsilateral breast); Ipsilateral second primary invasive breast cancer; Second primary non-breast invasive cancer; Contralateral invasive breast cancer; Distant recurrence (i.e., evidence of breast cancer in any anatomic site \[other than sites mentioned\]) that has either been histologically confirmed \&/or clinically/radiographically diagnosed as recurrent invasive breast cancer; Death attributable to any cause, including breast cancer, non-breast cancer, or unknown cause. Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis or no post-baseline information were censored.
    measure
    Invasive Disease-Free Survival (iDFS) Including Second Primary Non-Breast Invasive Cancer
    time Frame
    From randomization up to death from any cause (up to 5 years)
  5. description
    Recurrence-Free Interval (RFI) was defined as the time from randomization to the first occurrence of any recurrence (local, regional \[including invasive ipsilateral tumor and invasive locoregional tumor\], or distant), as determined by investigators. Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis, participants with no events who died, or participants with no post-baseline information were censored.
    measure
    Recurrence-Free Interval (RFI)
    time Frame
    From randomization up to 5 years
  6. description
    Distant Recurrence-Free Interval (DRFI) was defined as the time from randomization to the distant breast cancer recurrence. Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis, participants with no events who died, or participants with no post-baseline information were censored.
    measure
    Distant Recurrence-Free Interval (DRFI)
    time Frame
    From randomization up to 5 years
  7. description
    Disease-Free Survival (DFS) was defined as the time from randomization to the first occurrence of disease recurrence or death from any cause. DFS events include: Ipsilateral invasive breast tumor recurrence; Ipsilateral local-regional invasive breast cancer recurrence; Distant recurrence that has either been histologically confirmed or clinically diagnosed as recurrent invasive breast cancer; Contralateral invasive breast cancer; Ipsilateral or contralateral DCIS; Second primary non-breast invasive cancer; Death attributable to any cause. Analysis used Kaplan-Meier estimates where participants with no events at the time of analysis or no post-baseline information were censored.
    measure
    Disease-Free Survival (DFS)
    time Frame
    From randomization up to first disease recurrence or death from any cause (up to 5 years)
  8. description
    The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. For the role functioning scale, participant responses to the 2 questions "Q6: Were you limited in doing either your work or daily activities" and "Q7: Were you limited in pursuing your hobbies or other leisure time activities" were scored on a 4-point scale (1=Not at All to 4=Very Much). The scores were linearly transformed on a scale of 0 to 100, with a low score indicating better functioning. Negative change from baseline indicated improvement.
    measure
    Change From Baseline (CFB) in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Patient-reported Function (Role Functioning [Q6, Q7])
    time Frame
    Baseline (Cycle 1 Day 1), Day 1 of Cycles 4, 6, 8, 10, 12, 14 & 16; end of treatment/discontinuation (approximately at Day 351); Follow up: Months 3 to 48 (Total duration is up to 5 years); Cycles 1-5= 28 day cycles; Cycles 6-16: 21 day cycles
  9. description
    The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. For the physical functioning scale, participant responses to 5 questions about daily activities (strenuous activities, long walks, short walks, bed/chair rest \& needing help with eating, dressing, washing themselves, or using the toilet) were scored on a 4-point scale (1=Not at All to 4=Very Much). The scores were linearly transformed on a scale of 0 to 100, with a high score indicating worst functioning. Negative change from baseline indicated improvement in functioning.
    measure
    Change From Baseline in EORTC QLQ-C30 Patient-reported Function (Physical Functioning [Q1-Q5])
    time Frame
    Baseline (Cycle 1 Day 1), Day 1 of Cycles 4, 6, 8, 10, 12, 14 & 16; end of treatment/discontinuation (approximately at Day 351); Follow up: Months 3 to 48 (Total duration is up to 5 years); Cycles 1-5= 28 day cycles; Cycles 6-16: 21 day cycles
  10. description
    The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to the questions regarding Global Health Status (Q29:GHS; "How would you rate your overall health during the past week?") and Quality of Life (Q30: QoL; "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better outcome. Negative change from Baseline values indicated deterioration in QOL or functioning and positive values indicated improvement.
    measure
    Change From Baseline in EORTC QLQ-C30 Global Health Status (GHS) [Q29] and Health-Related Quality of Life (HRQoL) [Q30] Combined Score
    time Frame
    Baseline (Cycle 1 Day 1), Day 1 of Cycles 4, 6, 8, 10, 12, 14 & 16; end of treatment/discontinuation (approximately 351 days); Follow up: Months 3 to 48 (Total duration is up to 5 years); Cycles 1-5= 28 day cycles; Cycles 6-16: 21 day cycles
  11. description
    An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs are reported based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0.
    measure
    Number of Participants With Adverse Events (AE)
    time Frame
    Up to 5 years
  12. measure
    Serum Concentration of Atezolizumab
    time Frame
    Postdose Day 1 of Cycle 1; Predose Day 1 of Cycles 2, 3, and 4; Predose Cycles 6, 10, and 14; Predose Day 2 of Cycle 16; Cycles 1-5= 28-day cycles; Cycles 6-16: 21-day cycles
Full study description
brief Summary
This study will evaluate the efficacy, safety, and pharmacokinetics of adjuvant atezolizumab in combination with paclitaxel, followed by atezolizumab, dose-dense doxorubicin or epirubicin (investigator's choice), and cyclophosphamide, compared with paclitaxel followed by dose-dense doxorubicin or epirubicin (investigator's choice) and cyclophosphamide alone in patients with Stage II-III TNBC (Triple Negative Breast Cancer)
Source references
references
  1. citation
    Ignatiadis M, Bailey A, McArthur H, El-Abed S, de Azambuja E, Metzger O, Chui SY, Dieterich M, Perretti T, Shearer-Kang E, Molinero L, Steger GG, Jassem J, Lee SC, Higgins M, Zarba J, Schmidt M, Gomez H, Guerrero Zotano A, Moscetti L, Chiu J, Munzone E, Ben-Baruch NE, Bajetta E, Ohno S, Im SA, Werutsky G, Gal-Yam EN, Gonzalez Farre X, Tseng LM, Jacot W, Gluz O, Shao Z, Shparyk Y, Zimina A, Winer E, Cameron DA, Viale G, Saji S, Gelber R, Piccart M. Adjuvant Atezolizumab for Early Triple-Negative Breast Cancer: The ALEXANDRA/IMpassion030 Randomized Clinical Trial. JAMA. 2025 Jan 30;333(13):1150-60. doi: 10.1001/jama.2024.26886. Online ahead of print.
    pmid
    39883436
    type
    DERIVED
  2. citation
    Perez-Garcia J, Soberino J, Racca F, Gion M, Stradella A, Cortes J. Atezolizumab in the treatment of metastatic triple-negative breast cancer. Expert Opin Biol Ther. 2020 Sep;20(9):981-989. doi: 10.1080/14712598.2020.1769063. Epub 2020 May 25.
    pmid
    32450725
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-7ad944f6deaf1f5cd6122126
      edge id
      nct-edge-5d4a4097d967c3aa30f5
      requested nct id
      NCT03498716
      primary nct id
      NCT03498716
      source kind
      nci_explicit_reference_or_link
      source record id
      Source null
      source file sha256
      862f78faa9e4cbedc19f9ffcaeba97e029ba51b72bb3b81fc67aa8b6adf96904
      payload sha256
      d5296be2b1eea42e3e6e105921ee5b57dbb911385eff4712c767071b263fd6a0
      payload
      clinical indication matching status
      not_inferred
      end exclusive
      true
      id
      nct-edge-5d4a4097d967c3aa30f5
      link basis
      explicit_NCT_identifier_in_acquired_source
      nct id
      NCT03498716
      occurrences
      1. context exact
        id="_3635" tabindex="-1">Evidence (postoperative atezolizumab):</p> <div class="pdq-content-list"><ol id="_3636"><li> In the <a href="/clinicaltrials/NCT03498716">ALEXANDRA/IMpassion030</a> trial (NCT03498716), 2,199 women who had not received preoperative systemic therapy were randomly assigned postoperatively to recei
        end
        394981
        exact text
        NCT03498716
        start
        394970
      2. context exact
        e atezolizumab):</p> <div class="pdq-content-list"><ol id="_3636"><li> In the <a href="/clinicaltrials/NCT03498716">ALEXANDRA/IMpassion030</a> trial (NCT03498716), 2,199 women who had not received preoperative systemic therapy were randomly assigned postoperatively to receive chemotherapy with or without atezolizumab. T
        end
        395028
        exact text
        NCT03498716
        start
        395017
      offset unit
      unicode_code_points
      source file
      /tmp/cancer-full-research/nci/raw/29bf1e5a1d739974ed.html
      source file sha256
      862f78faa9e4cbedc19f9ffcaeba97e029ba51b72bb3b81fc67aa8b6adf96904
      source json pointer
      Source null
      source kind
      nci_explicit_reference_or_link
      source record id
      Source null
      source retrieved at
      2026-09-09T23:21:35.419733+00:00
      source string basis
      UTF-8_text_with_universal_newline_translation
      source string sha256
      536430925e3b0008edd3fb69a869d5645bd6b6dc5c84c21ddf1b3e24f089874c
      source title
      Breast Cancer Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: April 25, 2025
        datetime
        2025-04-25T12:00:00Z
        display
        April 25, 2025

    Preserved source evidence · Not medical advice