A Phase II Study Evaluating the Efficacy and Safety of Pembrolizumab in Combination With Chemotherapy as Neoadjuvant Therapy for Triple-negative Breast Cancer

NCT05681728 | Unknown Phase 2

• 1 other identifier: NCC3340
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase II study that evaluating the efficacy and safety of pembrolizumab in combination with chemotherapy as neoadjuvant therapy for triple-negative breast cancer in the Chinese population

Conditions

Breast Cancer

Keywords

breast cancer; neoadjuvant therapy; immunotherapy

Outcome Measures

Primary Outcomes (1)

• Pathological complete response (pCR) rate using the definition of ypT0/Tis ypN0 (i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery

  pCR rate (ypT0/Tis ypN0) is defined as the percentage of participants without residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy by current American Joint Committee on Cancer (AJCC) staging criteria assessed by the local pathologist at the time of definitive surgery.

  Up to approximately 27-30 weeks

Secondary Outcomes (2)

• Event-free Survival (EFS) as assessed by Investigator

  Up to approximately 8 years

• Percentage of participants who experience an adverse event (AE)

  Up to approximately 52 weeks

Study Arms (1)

Pembrolizumab combined with chemotherapy

EXPERIMENTAL

Drug: Pembrolizumab; Drug: Paclitaxel; Drug: Epirubicin; Drug: Cyclophosphamide

Interventions

Pembrolizumab DRUG

On Day 1 of each cycle in the neoadjuvant and adjuvant phases of the study for a total of 17 cycles; intravenous (IV) infusion

Pembrolizumab combined with chemotherapy

Paclitaxel DRUG

On Day 1 of Cycles 1-4 in the neoadjuvant phase of the study; IV infusion

Pembrolizumab combined with chemotherapy

Epirubicin DRUG

On Day 1 of Cycles 5-8 of the neoadjuvant phase of the study; IV injection

Pembrolizumab combined with chemotherapy

Cyclophosphamide DRUG

On Day 1 of Cycles 5-8 of the neoadjuvant phase of the study; IV infusion

Pembrolizumab combined with chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women who are 18 years of age or older on the date of signing the informed consent form.
• Pathologically confirmed invasive ductal carcinoma of the breast with stage T1c and N 1-3, or cT2-T4/N0-3.
• Patients with triple-negative breast cancer according to the most recent American Society of Clinical Oncology/American College of Pathologists guidelines.
• Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performed within 10 days of treatment initiation.
• Female subjects were not pregnant, breastfeeding, and had been on birth control for at least 24 months after the last dose.
• Subjects can sign informed consent to participate in the study. Appropriate organ function; All screening period laboratory tests should be completed within 10 days prior to the start of study therapy.

You may not qualify if:

• Has a history of invasive malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
• Has received prior chemotherapy, targeted therapy, and radiation therapy within the past 12 months.
• Has received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-programmed death - ligand 1 (anti-PD-L1), or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated antigen-4 \[CTLA-4\], OX-40, CD137 \[tumor necrosis factor receptor superfamily member 9 (TNFRSF9)\]) or has previously participated in a pembrolizumab (MK-3475) clinical study.
• Is currently participating in or has participated in an interventional clinical study with an investigational compound or device within 4 weeks of the first dose of treatment in this current study.
• Has received a live vaccine within 30 days of the first dose of study treatment.
• Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
• Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (i.e., dosing exceeding 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
• Has a known history of Human Immunodeficiency Virus (HIV). Has known active Hepatitis B or Hepatitis C. Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
• Has an active infection requiring systemic therapy. Has significant cardiovascular disease, such as: history of myocardial infarction, acute coronary syndrome or coronary angioplasty/stenting/bypass grafting within the last 6 months OR congestive heart failure (CHF) New York Heart Association (NYHA) Class II-IV or history of CHF NYHA Class III or IV.
• Is pregnant or breastfeeding, or expecting to conceive children within the projected duration of the study, starting with the screening visit through 12 months after the last dose of study treatment for participants who have received cyclophosphamide, and for 6 months after the last dose of study treatment for participants who have not.
• Has a known hypersensitivity to the components of the study treatment or its analogs.
• Has a known history of active tuberculosis (TB, Bacillus Tuberculosis).

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

pembrolizumab; Paclitaxel; Epirubicin; Cyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds

Central Study Contacts

Fei Ma

CONTACT

010-87788120; drmafei@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of the Department of Medical Oncology

Study Record Dates

• First Submitted: December 28, 2022
• First Posted: January 12, 2023
• Study Start: February 1, 2022
• Primary Completion: February 1, 2024
• Study Completion: June 1, 2024
• Last Updated: January 12, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)