Clinical Trials /

Study of Nivolumab Versus Placebo in Participants With High-Risk Breast Cancer

NCT04109066

Description:

A randomized multi-arm study evaluating the safety and efficacy of nivolumab versus placebo in combination with paclitaxel in participants with ER+/HER2- breast cancer

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Study of Nivolumab Versus Placebo in Participants With High-Risk Breast Cancer
  • Official Title: A Randomized, Multicenter, Double-blind, Placebo-controlled Phase 3 Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Patients With High-risk, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast Cancer

Clinical Trial IDs

  • ORG STUDY ID: CA209-7FL
  • NCT ID: NCT04109066

Conditions

  • Breast Cancer

Interventions

DrugSynonymsArms
nivolumabArm A: Nivolumab combined with neoadjuvant CT and adjuvant ET
paclitaxel (PTX)Arm A: Nivolumab combined with neoadjuvant CT and adjuvant ET
anthracyclineArm A: Nivolumab combined with neoadjuvant CT and adjuvant ET
cyclophosphamideArm A: Nivolumab combined with neoadjuvant CT and adjuvant ET
Endocrine TherapyArm A: Nivolumab combined with neoadjuvant CT and adjuvant ET

Purpose

A randomized multi-arm study evaluating the safety and efficacy of nivolumab versus placebo in combination with paclitaxel in participants with ER+/HER2- breast cancer

Trial Arms

NameTypeDescriptionInterventions
Arm A: Nivolumab combined with neoadjuvant CT and adjuvant ETExperimentalNivolumab with paclitaxel followed by nivolumab with anthracycline + cyclophosphamide as neoadjuvant (pre-surgery) treatment, then nivolumab with adjuvant (post-surgery) endocrine therapy of investigator's choice
  • nivolumab
  • paclitaxel (PTX)
  • anthracycline
  • cyclophosphamide
  • Endocrine Therapy
Arm B: Placebo combined with neoadjuvant CT and adjuvant ETPlacebo ComparatorNivolumab placebo with paclitaxel followed by nivolumab with anthracycline + cyclophosphamide as neoadjuvant (pre-surgery) treatment, then nivolumab with adjuvant (post-surgery) endocrine therapy of investigator's choice
  • paclitaxel (PTX)
  • anthracycline
  • cyclophosphamide
  • Endocrine Therapy

Eligibility Criteria

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com.

        Inclusion Criteria:

          -  Participant has untreated, unilateral invasive, histologically confirmed, localized
             invasive breast ductal carcinoma that includes either T1c-T2 (tumor size ≥2 cm),
             clinical node stage (cN)1-cN2, or T3-T4, cN0-cN2. Note: Inflammatory breast cancer is
             allowed.

          -  Participant has centrally confirmed ER+ invasive breast cancer with or without
             progesterone receptor expression, according to the most recent American Society of
             Clinical Oncology/College of American Pathologist guidelines.

          -  Participant must agree to provide tumor tissue at baseline and at surgery.

          -  Participant must be deemed eligible for neoadjuvant chemotherapy.

          -  Participant must be deemed eligible for surgery and must agree to undergo surgery
             after completion of neoadjuvant therapy.

          -  Women and men must agree to follow instructions for methods of contraception.

          -  Participant must have an Eastern Cooperative Oncology Group (ECOG) scale performance
             status of 0 or 1.

        Exclusion Criteria:

          -  Participant who is breastfeeding, pregnant, or expecting to conceive or father
             children within the projected duration of the study, starting with the screening
             through 12 months for participants who receive cyclophosphamide, or 6 months for
             participants who do not receive cyclophosphamide, after the last dose of study
             treatment.

          -  Prior treatment with chemotherapy, endocrine therapy, targeted therapy, and/or
             radiation administered for the currently diagnosed breast cancer, or where upfront
             chemotherapy is judged clinically inappropriate as optimal neoadjuvant treatment.

          -  Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or
             any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint
             pathways, or history of allergy, or hypersensitivity to study medication.

          -  Participant has significant cardiovascular disease such as left ventricular ejection
             fraction (LVEF) < 50% at baseline as assessed by echocardiography (ECHO) or multigated
             acquisition (MUGA) scan performed at screening, or Class III or IV myocardial disease
             as described by the New York Heart Association.

        Other inclusion/exclusion criteria may apply.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Pathological Complete response (pCR) Pathological Complete response (pCR) Using the definition of ypT0/Tis ypN0
Time Frame:approximately 7 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Overall Survival (OS)
Time Frame:up to 10 years
Safety Issue:
Description:
Measure:Disease-free Survival (DFS)
Time Frame:up to 10 years
Safety Issue:
Description:
Measure:Distant Metastasis-free survival (DMFS)
Time Frame:up to 10 years
Safety Issue:
Description:
Measure:Pathological Complete Response (pCR) using the definition of ypT0ypN0
Time Frame:approximately 7 months
Safety Issue:
Description:
Measure:Pathological Complete Response (pCR) rate using the definition of ypT0/is
Time Frame:approximately 7 months
Safety Issue:
Description:
Measure:Objective Response Rate (ORR)
Time Frame:approximately 7 months
Safety Issue:
Description:
Measure:Breast Conserving Surgery (BCS) rate
Time Frame:approximately 7 months
Safety Issue:
Description:
Measure:Number of participants experiencing an adverse event (AE)
Time Frame:approximately 17 months
Safety Issue:
Description:
Measure:Change from baseline on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 Score (EORTC QLQ-C30) global health status/quality of life (QOL) subscale (items 29 and 30)
Time Frame:up to 52 weeks
Safety Issue:
Description:
Measure:Change from baseline on the EORTC QLQ-C30 physical functioning subscale (items 1 to 5)
Time Frame:up to 52 weeks
Safety Issue:
Description:

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Bristol-Myers Squibb

Trial Keywords

  • Nivolumab
  • Breast Cancer
  • Cancer
  • Estrogen Receptor-Positive(ER+)
  • Human Epidermal Growth Factor 2 Negative (HER2-)
  • Neoadjuvant
  • Adjuvant
  • Primary Breast Cancer

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