Trial record 1 of 1 for:
NCT04075604
A Study of Neoadjuvant Nivolumab + Palbociclib + Anastrozole in Post-Menopausal Women and Men With Primary Breast Cancer (CheckMate 7A8)
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| ClinicalTrials.gov Identifier: NCT04075604 |
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Recruitment Status :
Recruiting
First Posted : September 3, 2019
Last Update Posted : October 22, 2020
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Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
- Study Details
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Brief Summary:
A randomized multi-arm study evaluating the safety and efficacy of palbociclib and anastrozole with or without nivolumab in participants with ER+/HER2- breast cancer
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Breast Cancer Cancer | Biological: Nivolumab Drug: Anastrozole Drug: Palbociclib | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 136 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Randomized, Non-comparative Neoadjuvant Phase II Study in Patients With ER+/HER2- Breast Cancer >= 2 cm With Safety Run-in, Assessing Nivolumab + Palbociclib + Anastrozole |
| Actual Study Start Date : | October 9, 2019 |
| Estimated Primary Completion Date : | April 28, 2022 |
| Estimated Study Completion Date : | April 28, 2022 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Breast cancer
MedlinePlus related topics:
Breast Cancer
| Arm | Intervention/treatment |
|---|---|
| Experimental: Arm A: Nivolumab+Palbociclib+Anastrozole (ANZ) |
Biological: Nivolumab
Specified Dose on Specified Days Drug: Anastrozole Specified Dose on Specified Days Drug: Palbociclib Specified Dose on Specified Days |
| Experimental: Arm B: Palbociclib+ANZ then Nivolumab+Palbociclib+ANZ |
Biological: Nivolumab
Specified Dose on Specified Days Drug: Anastrozole Specified Dose on Specified Days Drug: Palbociclib Specified Dose on Specified Days |
| Active Comparator: Arm C: Palbociclib+ANZ |
Drug: Anastrozole
Specified Dose on Specified Days Drug: Palbociclib Specified Dose on Specified Days |
Primary Outcome Measures :
- Dose Limiting Toxicity [ Time Frame: up to 4 weeks ]
- Residual Cancer Burden RCB (0-1) rate by central assessment [ Time Frame: up to 20 weeks ]
Secondary Outcome Measures :
- Incidence of Adverse Events (AEs) [ Time Frame: up to 34 weeks ]
- Incidence of Serious Adverse Events (SAE) [ Time Frame: up to 34 weeks ]
- AEs leading to Discontinuation [ Time Frame: up to 34 weeks ]
- Immune-related AEs [ Time Frame: up to 34 weeks ]
- Number of laboratory abnormalities [ Time Frame: up to 34 weeks ]
- Pathological Complete Response (pCR) by local assessment [ Time Frame: up to 20 weeks ]
- Objective Response Rate (ORR) [ Time Frame: up to 20 weeks ]
- Breast Conserving Surgery (BCS) rate [ Time Frame: up to 20 weeks ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com.
Inclusion Criteria:
- Participants must have untreated, unilateral, histologically confirmed ER+, HER2- invasive breast cancer with primary tumor ≥2 cm in largest diameter (cT1-3) in one dimension by clinical or radiographic exam, for whom neoadjuvant endocrine monotherapy deemed to be a suitable therapy.
- Participants must be deemed eligible for surgery and must agree to undergo surgery after completion of neoadjuvant therapy and agree to provide tumor tissue at baseline, on-treatment, and at surgery.
- Women must have documented proof that they are not of childbearing potential.
- Participants must have a performance status (PS) ≤ 1 on the Eastern Cooperative Oncology Group (ECOG) scale
Exclusion Criteria:
- Participants who may have had any treatment, including radiotherapy, chemotherapy, and/or targeted therapy administered for the currently diagnosed breast cancer prior to enrollment or for whom upfront chemotherapy is clinically judged appropriate as optimal neoadjuvant treatment.
- Participants who have a history of or active, known or suspected autoimmune disease, or other syndrome that requires systemic steroids above physiological replacement dose or autoimmune agents for the past 2 years.
- Prior treatment with either ET or CDK4/6 inhibitors for Breast Cancer (BC) within 5 years or 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 drug components
- Prior malignancy active within the previous 3 years or participants with serious or uncontrolled medical disorders.
- Personal history of any of the following conditions: syncope of either unexplained or cardiovascular etiology, ventricular arrhythmia (including but not limited to ventricular tachycardia and ventricular fibrillation), long or short QT syndrome, Brugada syndrome, or known history of corrected QT prolongation, Torsade de Pointes, or sudden cardiac arrest.
Other protocol-defined inclusion/exclusion criteria apply.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04075604
Contacts
| Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information | please email: | Clinical.Trials@bms.com | |
| Contact: First line of the email MUST contain NCT # and Site # |
Locations
Show 66 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT04075604 |
| Other Study ID Numbers: |
CA209-7A8 |
| First Posted: | September 3, 2019 Key Record Dates |
| Last Update Posted: | October 22, 2020 |
| Last Verified: | October 2020 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Bristol-Myers Squibb:
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Nivolumab Breast Cancer Cancer |
ER+ HER2- Neoadjuvant |
Additional relevant MeSH terms:
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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Nivolumab Palbociclib Anastrozole Antineoplastic Agents, Immunological Antineoplastic Agents |
Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Hormonal Aromatase Inhibitors Steroid Synthesis Inhibitors Estrogen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |