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) (BCTOP-T-N01)

• ClinicalTrials.gov Identifier: NCT05999149
• Recruitment Status: Recruiting
• First Posted: August 21, 2023
• Last Update Posted: February 21, 2024
• Sponsor: Fudan University
• Information provided by (Responsible Party): Zhimin Shao, Fudan University

Tracking Information

• First Submitted Date: August 13, 2023
• First Posted Date: August 21, 2023
• Last Update Posted Date: February 21, 2024
• Actual Study Start Date: August 20, 2023
• Estimated Primary Completion Date: August 30, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 17, 2023)

Pathological complete response (pCR) rate [ Time Frame: Up to approximately 24 weeks ]

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 17, 2023)

• Event-free Survival (EFS) as assessed by Investigator [ Time Frame: At least 2 years ]
  EFS is defined as the time from randomization to any of the following events: progression of disease that precludes surgery, local or distant recurrence, second primary malignancy (breast or other cancers) or death due to any cause.
• Disease-free Survival (DFS) as assessed by Investigator [ Time Frame: At least 2 years ]
  DFS is defined as the time from surgery to any of the following events: local or distant recurrence, or death due to any cause.
• Distant Disease-free Survival (DDFS) as assessed by Investigator [ Time Frame: At least 2 years ]
  DDFS is defined as the time from surgery to distant recurrence, or death due to any cause.
• Objective response rate (ORR) in accordance with RECIST v1.1 [ Time Frame: 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.
• Number of responders Assessed by Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1) for target lesions assessed by MRI. [ Time Frame: Up to approximately 67 weeks ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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)
• Official Title: A Randomized, Open Label, Multicenter Phase III Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: TNBC - Triple-Negative Breast Cancer

Intervention

• Drug: Camrelizumab Plus Chemotherapy and Famitinib
  camrelizumab+chemotherapy (Albumin-paclitaxel plus carboplatin)+Famitinib
  Other Name: camrelizumab+chemotherapy+Famitinib
• Drug: Camrelizumab Plus Chemotherapy
  Camrelizumab Plus Chemotherapy

Study Arms

• Experimental: Arm A
  Camrelizumab Plus Chemotherapy and Famitinib
  Intervention: Drug: Camrelizumab Plus Chemotherapy and Famitinib
• Active Comparator: Arm B
  Camrelizumab Plus Chemotherapy
  Intervention: Drug: Camrelizumab Plus Chemotherapy

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 17, 2023): 424
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 30, 2027
• Estimated Primary Completion Date: August 30, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion 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;

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: chen li, MD; +86-021-64175590; chen_li@fudan.edu.cn

• Listed Location Countries: China

Administrative Information

• NCT Number: NCT05999149
• Other Study ID Numbers: BCTOP-T-N01
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Zhimin Shao, Fudan University
• Original Responsible Party: Same as current
• Current Study Sponsor: Fudan University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Fudan University
• Verification Date: February 2024