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)

NCT ID: NCT05999149

Last Updated: 2024-02-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 424 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-20
• Study Completion Date: 2027-08-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A

Camrelizumab Plus Chemotherapy and Famitinib

Group Type: EXPERIMENTAL

Camrelizumab Plus Chemotherapy and Famitinib

Intervention Type: DRUG

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

Arm B

Camrelizumab Plus Chemotherapy

Group Type: ACTIVE_COMPARATOR

Camrelizumab Plus Chemotherapy

Intervention Type: DRUG

Camrelizumab Plus Chemotherapy

Interventions

Camrelizumab Plus Chemotherapy and Famitinib

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

Intervention Type: DRUG

Camrelizumab Plus Chemotherapy

Camrelizumab Plus Chemotherapy

Intervention Type: DRUG

Other Intervention Names

camrelizumab+chemotherapy+Famitinib

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

• 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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Zhimin Shao

Director of General Surgery of Fudan Shanghai Cancer Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Breast cancer institute of Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Fudan University Shanghai Cancer Center Shanghai, China, 200032

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

chen li, MD

Role: CONTACT

chen_li@fudan.edu.cn

+86-021-64175590

Facility Contacts

Zhi-Ming Shao, MD

Role: primary

zhimingshao@yahoo.com

86-21-641755901105

Lei Fan, MD

Role: backup

cmchen@medmail.com.cn

86-21-641755901105

Zhimin Shao, M.D.

Role: primary

zhimingshao@yahoo.com

+86-021-64175590 ext. 88807

Linxiaoxi Ma, M.D

Role: backup

mary2008white@126.com

+86-021-64175590 ext. 63169

Other Identifiers

BCTOP-T-N01

Identifier Type: -

Identifier Source: org_study_id