A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)

NCT05999149 | Recruiting Phase 3

• 1 other identifier: BCTOP-T-N01
• Study Type: interventional
• Target: 424
• Locations: 1 country
• Sites: 2

Brief Summary

This is an open, randomized, controlled, multicenter Phase III clinical study. Eligible subjects were randomly assigned 1:1 to albumin-paclitaxel plus carboplatin and carrilizumab with or without famitinib neoadjuvant therapy. Stratification was performed at randomization according to the following factors: clinical stage of the tumor (stage II; Stage III) and CD8 expression status (IHC ≥10%, \< 10%). Subjects who have completed neoadjuvant therapy and are suitable for surgery are required to undergo surgery. Subjects in the experimental group will continue to receive carrilizumab and famitinib until one year from the start of neoadjuvant therapy, and subjects in the control group will continue to receive carrilizumab until one year from the start of neoadjuvant therapy. Subjects who completed neoadjuvant therapy were required to undergo imaging efficacy evaluation according to RECIST1.1 before surgery; subjects suitable for surgery received surgical treatment, and pathological evaluation of tumor efficacy was performed after surgery. During the study treatment, if the subjects show disease progression, toxicity intolerance, withdrawal of informed consent, or the investigator determines that medication must be terminated, the study treatment will be terminated, and follow-up will continue, including disease recurrence and metastasis and safety follow-up. Participants who complete surgical treatment will be followed for at least 2 years for event-free survival (EFS), disease-free survival (DFS), distant metastasis-free survival (DDFS), and safety assessment. Safety data should be collected from the signing of the informed consent until 28 days after the end of the study.

Conditions

TNBC - Triple-Negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Pathological complete response (pCR) rate

  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

  Up to approximately 24 weeks

Secondary Outcomes (5)

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

  At least 2 years

• Disease-free Survival (DFS) as assessed by Investigator

  At least 2 years

• Distant Disease-free Survival (DDFS) as assessed by Investigator

  At least 2 years

• Objective response rate (ORR) in accordance with RECIST v1.1

  Up to approximately 24 weeks

• Number of responders Assessed by Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1) for target lesions assessed by MRI.

  Up to approximately 67 weeks

Study Arms (2)

Arm A

EXPERIMENTAL

Camrelizumab Plus Chemotherapy and Famitinib

Drug: Camrelizumab Plus Chemotherapy and Famitinib

Arm B

ACTIVE COMPARATOR

Camrelizumab Plus Chemotherapy

Drug: Camrelizumab Plus Chemotherapy

Interventions

Camrelizumab Plus Chemotherapy and Famitinib DRUG

camrelizumab+chemotherapy (Albumin-paclitaxel plus carboplatin)+Famitinib

Also known as: camrelizumab+chemotherapy+Famitinib

Arm A

Camrelizumab Plus Chemotherapy DRUG

Camrelizumab Plus Chemotherapy

Arm B

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ECOG Performance Status of 0-1. Early or locally advanced, histologically documented TNBC (absence of HER2, ER, and PR expression).
• Tumor stage: II-III. Adequate hematologic and organ function. Must be willing to use an adequate method of contraception for the course of the study.

You may not qualify if:

• Has a history of breast cancer. 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 \[CTLA-4\].
• Has a diagnosis of immunodeficiency or autoimmune diseases. Has received any form of immunosuppressive therapy within 4 weeks prior to the first dose of study treatment.
• Severe pulmonary or cardiac disease. Known active hepatitis C virus, or known active hepatitis B virus. History of organ or bone marrow transplantation. Pregnant or breast-feeding women. Patients who have previously received VEGFR-like small molecule tyrosine kinase inhibitors (such as famitinib, sorafenib, Sunitinib, regorafenib, etc.) (except bevacizumab); Urine routine indicated urinary protein ≥2+ and confirmed urinary protein quantity \> 1g at 24h;

Sponsors & Collaborators

• Fudan University: lead

Study Sites (2)

Breast cancer institute of Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Fudan University Shanghai Cancer Center Shanghai, China, 200032

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

camrelizumab; Drug Therapy; famitinib

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

chen li, MD

CONTACT

+86-021-64175590; chen_li@fudan.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of General Surgery of Fudan Shanghai Cancer Center

Study Record Dates

• First Submitted: August 13, 2023
• First Posted: August 21, 2023
• Study Start: August 20, 2023
• Primary Completion: August 30, 2025
• Study Completion (Estimated): August 30, 2027
• Last Updated: February 21, 2024

Record last verified: 2024-02

Locations

CN (2)