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Trial record 1 of 1 for:    NCT04075604
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A Study of Neoadjuvant Nivolumab + Abemaciclib or Palbociclib + Anastrozole in Post-Menopausal Women and Men With Primary Breast Cancer (CheckMate 7A8)

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ClinicalTrials.gov Identifier: NCT04075604
Recruitment Status : Recruiting
First Posted : September 2, 2019
Last Update Posted : November 26, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief Summary:
A randomized multi-arm study evaluating the safety and efficacy of abemaciclib or 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: Abemaciclib Drug: Anastrozole Drug: Palbociclib Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 268 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 + Abemaciclib or Palbociclib + Anastrozole
Actual Study Start Date : October 9, 2019
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : September 20, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm A: Nivolumab +Abemaciclib+Anastrozole (ANZ) Biological: Nivolumab
Specified Dose on Specified Days

Drug: Abemaciclib
Specified Dose on Specified Days

Drug: Anastrozole
Specified Dose on Specified Days
Experimental: Arm B: Abemaciclib+ANZ then Nivolumab+Abemaciclib+ANZ Biological: Nivolumab
Specified Dose on Specified Days

Drug: Abemaciclib
Specified Dose on Specified Days

Drug: Anastrozole
Specified Dose on Specified Days
Active Comparator: Arm C: Abemaciclib+ANZ Drug: Abemaciclib
Specified Dose on Specified Days

Drug: Anastrozole
Specified Dose on Specified Days
Experimental: Arm D: Nivolumab+Palbociclib+ANZ Biological: Nivolumab
Specified Dose on Specified Days

Drug: Anastrozole
Specified Dose on Specified Days

Drug: Palbociclib
Specified Dose on Specified Days
Experimental: Arm E: 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 F: Palbociclib+ANZ Drug: Anastrozole
Specified Dose on Specified Days

Drug: Palbociclib
Specified Dose on Specified Days


Outcome Measures
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Primary Outcome Measures :
  1. Dose Limiting Toxicity [ Time Frame: up to 4 weeks ]
  2. Residual Cancer Burden RCB (0-1) rate by central assessment [ Time Frame: up to 20 weeks ]

Secondary Outcome Measures :
  1. Incidence of Adverse Events (AEs) [ Time Frame: up to 34 weeks ]
  2. Incidence of Serious Adverse Events (SAE) [ Time Frame: up to 34 weeks ]
  3. AEs leading to Discontinuation [ Time Frame: up to 34 weeks ]
  4. Immune-related AEs [ Time Frame: up to 34 weeks ]
  5. Number of laboratory abnormalities [ Time Frame: up to 34 weeks ]
  6. Pathological Complete Response (pCR) by local assessment [ Time Frame: up to 20 weeks ]
  7. Objective Response Rate (ORR) [ Time Frame: up to 20 weeks ]
  8. Breast Conserving Surgery (BCS) rate [ Time Frame: up to 20 weeks ]

Eligibility Criteria
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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.
  • ECOG <=1.

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 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 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 as well as 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 inclusion/exclusion criteria apply.

Contacts and Locations
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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
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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 #

  Show 62 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:
BMS Clinical Trial Information  This link exits the ClinicalTrials.gov site BMS Clinical Trial Patient Recruiting  This link exits the ClinicalTrials.gov site Investigator Inquiry Form  This link exits the ClinicalTrials.gov site FDA Safety Alerts and Recalls  This link exits the ClinicalTrials.gov site

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT04075604     History of Changes
Other Study ID Numbers: CA209-7A8
First Posted: September 2, 2019    Key Record Dates
Last Update Posted: November 26, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bristol-Myers Squibb:
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