Clinical trial NCT05999149: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: TNBC - Triple-Negative Breast Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 424
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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;

Primary outcomes:
measure: Pathological complete response (pCR) rate
timeFrame: Up to approximately 24 weeks
Secondary outcomes:
measure: Event-free Survival (EFS) as assessed by Investigator
timeFrame: At least 2 years
measure: Disease-free Survival (DFS) as assessed by Investigator
timeFrame: At least 2 years
measure: Distant Disease-free Survival (DDFS) as assessed by Investigator
timeFrame: At least 2 years
measure: Objective response rate (ORR) in accordance with RECIST v1.1
timeFrame: Up to approximately 24 weeks
measure: Number of responders Assessed by Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1) for target lesions assessed by MRI.
timeFrame: Up to approximately 67 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Breast cancer institute of Fudan University Cancer Hospital
state: Shanghai
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center Shanghai, China, 200032
state: Shanghai
Study officials:
References: