Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Paclitaxel

Cyclophosphamide

Albumin-Bound Paclitaxel

Estrogens

Nivolumab

Mitogens

Tubulin Modulators

Antimitotic Agents

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Nivolumab 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 placebo with paclitaxel followed by nivolumab placebo with anthracycline + cyclophosphamide as neoadjuvant (pre-surgery) treatment, then adjuvant (post-surgery) endocrine therapy of investigator's choice

nivolumab

paclitaxel (PTX)

nivolumab placebo

anthracycline

cyclophosphamide

Variable endocrine therapy of investigators choice

Endocrine Therapy

Surgery

Bristol-Myers Squibb

A randomized multi-arm study evaluating the efficacy and safety of nivolumab versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant (post-surgery) endocrine therapy in participants with high-risk, estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+, HER2-) early stage breast cancer.

Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Participants With High-risk, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast Cancer

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

pCR rate is defined as the percentage of participants who achieved pCR. pCR is defined as no invasive residual disease in breast and lymph nodes performed by a local pathologist. Criteria for evaluation of pCR includes the following: pCR in breast, axillary lymph nodes and non-axillary sentinel node; no histologic evidence of invasive tumor cells; and pCR in the breast.

RCB is estimated from routine pathologic sections of the primary breast tumor site and the regional lymph nodes after the completion of neoadjuvant therapy. RCB is categorized into the following 4 classes: RCB-0: no residual disease; RCB-1: minimal residual disease; RCB-II: moderate residual disease; RCB-III: and extensive residual disease.

Number of participants with any grade adverse events (AEs). An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relation with this treatment. Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Number of participants with any grade serious adverse events (SAE). SAE is defined as any untoward medical occurrence that, at any dose: Results in death; is life threatening; requires inpatient hospitalization; results in persistent or significant disability; is a congenital anomaly/birth defect. Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Number of participants who died due to any cause.

The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.

The 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.

Neoadjuvant (Pre-surgery) Phase 8 cycles maximum:

Paclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab 360 mg Q3W + PTX QW

Followed by:

Anthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q3W):

Nivolumab 360 mg Q3W + AC Q3W

Surgery and Adjuvant (Post-surgery) Phase 7 cycles maximum:

Adjuvant Cycles 1-7 (1 cycle = Q4W):

Nivolumab 480 mg Q4W + Endocrine Therapy (ET)

Arm A: Nivo + Chemo (PTX QW + AC Q3W) / Nivo + ET

Neoadjuvant (Pre-surgery) Phase 8 cycles maximum:

Paclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab 360 mg Q3W + PTX QW

Followed by:

Anthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W):

Nivolumab 240 mg Q2W + AC Q2W

Surgery and Adjuvant (Post-surgery) Phase 7 cycles maximum:

Adjuvant Cycles 1-7 (1 cycle = Q4W):

Nivolumab 480 mg Q4W + Endocrine Therapy (ET)

Arm A: Nivo + Chemo (PTX QW + AC Q2W) / Nivo + ET

Neoadjuvant (Pre-surgery) Phase 8 cycles maximum:

Paclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab Placebo Q3W + PTX QW

Followed by:

Anthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q3W):

Nivolumab Placebo Q3W + AC Q3W

Surgery and Adjuvant (Post-surgery) Phase 7 cycles maximum:

Adjuvant Cycles 1-7 (1 cycle = Q4W):

Endocrine Therapy (ET)

Arm B: Nivo Placebo + Chemo (PTX QW + AC Q3W) / ET

Neoadjuvant (Pre-surgery) Phase 8 cycles maximum:

Paclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab Placebo Q3W + PTX QW

Followed by:

Anthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W):

Nivolumab Placebo Q2W + AC Q2W

Surgery and Adjuvant (Post-surgery) Phase 7 cycles maximum:

Adjuvant Cycles 1-7 (1 cycle = Q4W):

Endocrine Therapy (ET)

Arm B: Nivo Placebo + Chemo (PTX QW + AC Q2W) / ET

Neoadjuvant (Pre-surgery) Phase 8 cycles maximum:

Paclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab 360 mg Q3W + PTX QW

Followed by:

Anthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W or Q3W):

Nivolumab 360 mg Q3W + AC Q3W or Nivolumab 240 mg Q2W + AC Q2W

Surgery and Adjuvant (Post-surgery) Phase 7 cycles maximum:

Adjuvant Cycles 1-7 (1 cycle = Q4W):

Nivolumab 480 mg Q4W + Endocrine Therapy (ET)

Arm A

Neoadjuvant (Pre-surgery) Phase 8 cycles maximum:

Paclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab Placebo Q3W + PTX QW

Followed by:

Anthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W or Q3W):

Nivolumab Placebo Q3W + AC Q3W or Nivolumab Placebo Q2W + AC Q2W

Surgery and Adjuvant (Post-surgery) Phase 7 cycles maximum:

Adjuvant Cycles 1-7 (1 cycle = Q4W):

Endocrine Therapy (ET)

Arm B

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Bristol-Myers Squibb Study Director

All randomized participants with sufficient follow-up for pCR assessment

Pathological Complete Response (pCR) Rate

All randomized participants in PD-L1 expression on immune cells \>=1% subgroup with sufficient follow-up for pCR assessment

Pathological Complete Response (pCR) Rate (PD-L1 >=1%)

RCB-0

RCB-I

RCB-II

RCB-III

Not Reported

All randomized participants with sufficient follow-up for RCB assessment

Number of Participants With Residual Cancer Burden (RCB)

All randomized participants in PD-L1 expression on immune cells \>=1% subgroup with sufficient follow-up for RCB assessment

Spots Global Cancer Trial Database for paclitaxel (ptx)