NCT04613674CompletedPhase 3
A Study of Camrelizumab Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC)
A Multicentre, Randomized, Double-blind, Parallel-controlled Phase Ⅲ Study to Evaluate Camrelizumab Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy in Patients With Early or Locally Advanced Triple Negative Breast Cancer (TNBC).
Source: ClinicalTrials.gov · Last updated 27 Mar 2024
Brief summary (registry, in English)
The purpose of this study is to evaluate the efficacy and safety of camrelizumab (an engineered anti-programmed death-ligand 1 \[PD-1\] antibody) plus chemotherapy vs placebo plus chemotherapy as neoadjuvant therapy in participants with triple negative breast cancer (TNBC). Participants will be randomized in a 1:1 ratio to Arm A (camrelizumab +chemotherapy) or Arm B (placebo + chemotherapy).
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 441 (actual)
- First submitted
- 29 Oct 2020
- Start date
- 9 Dec 2020
- Primary completion date
- 14 Sept 2023
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT04613674
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 441
- From 9 Dec 2020 to the primary completion date, 14 Sept 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has received prior chemotherapy, targeted therapy, and radiation therapy within the past 12 months.
- Has received any form of immunosuppressive therapy within 4 weeks prior to the first dose of study treatment.
Other illness
- Has a history of breast cancer.
- Has a diagnosis of immunodeficiency or autoimmune diseases.
- Severe pulmonary or cardiac disease.
- Known active hepatitis C virus, or known active hepatitis B virus.
- History of organ or bone marrow transplantation.
Lab values
- 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 \[CTLA-4\].
Age
- 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.
Other
- Pregnant or breast-feeding women.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fudan University Cancer hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.