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

Study Description

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.

Condition or disease	Intervention/treatment	Phase
TNBC - Triple-Negative Breast Cancer	Drug: Camrelizumab Plus Chemotherapy and Famitinib; Drug: Camrelizumab Plus Chemotherapy	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 424 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: August 20, 2023
• Estimated Primary Completion Date: August 30, 2025
• Estimated Study Completion Date: August 30, 2027

Arms and Interventions

Arm	Intervention/treatment
Experimental: Arm A; Camrelizumab Plus Chemotherapy and Famitinib	Drug: Camrelizumab Plus Chemotherapy and Famitinib; camrelizumab+chemotherapy (Albumin-paclitaxel plus carboplatin)+Famitinib; Other Name: camrelizumab+chemotherapy+Famitinib
Active Comparator: Arm B; Camrelizumab Plus Chemotherapy	Drug: Camrelizumab Plus Chemotherapy; Camrelizumab Plus Chemotherapy

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.
5. 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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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;

Contacts and Locations

Contacts

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

Locations

China, Shanghai

Breast cancer institute of Fudan University Cancer Hospital; Recruiting

Shanghai, Shanghai, China, 200032

Contact: Zhi-Ming Shao, MD 86-21-641755901105 zhimingshao@yahoo.com

Contact: Lei Fan, MD 86-21-641755901105 cmchen@medmail.com.cn

Principal Investigator: Zhi-Ming Shao, MD

Sub-Investigator: Li CHEN, MD

Fudan University Shanghai Cancer Center Shanghai, China, 200032; Recruiting

Shanghai, Shanghai, China, 200032

Contact: Zhimin Shao, M.D. +86-021-64175590 ext 88807 zhimingshao@yahoo.com

Contact: Linxiaoxi Ma, M.D +86-021-64175590 ext 63169 mary2008white@126.com

Sponsors and Collaborators

Fudan University

More Information

• Responsible Party: Zhimin Shao, Director of General Surgery of Fudan Shanghai Cancer Center, Fudan University
• ClinicalTrials.gov Identifier: NCT05999149
• Other Study ID Numbers: BCTOP-T-N01
• First Posted: August 21, 2023
• Last Update Posted: February 21, 2024
• Last Verified: February 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

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

Additional relevant MeSH terms:

Breast Neoplasms; Triple Negative Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases