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New treatment option for Her-2 Negative Breast Cancer
Official title Neoadjuvant Camrelizumab and Fluzoparib and Nab-paclitaxel in Early Breast Cancer With HRR Gene Mutation
ClinicalTrials.gov ID: NCT05761470
What this study is testing
What is Camrelizumab?
Camrelizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for her-2 negative breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is to evaluate the efficacy and safety of combination of Camrelizumab (Immunotherapy, PD-1 inhibitor), Fluzoparib (PARP inhibitor) and Nab-paclitaxel in neoadjuvant therapy of Her-2 negative breast cancer patients with HRR gene mutation.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Histologically documented Her-2 negative
- TNM stage: T1c, N1-N2；T2-4, N0-N2；any T, N3
- No distant metastatic disease
- Eastern Cooperative Oncology Group Performance Status: 0\~1
- HRR gene mutation: at least one pathogenic or likely pathogenic variant in germline or somatic BRCA1, BCRA2 and PALB2 genes, or in germline ATM...
You likely can't join if
- Patients who are pregnant or lactating at the time of randomization or refuse to contraception.
- Patients who have other malignant diseases within 2 years, except for cured skin basal cell carcinoma, breast carcinoma in situ or cervical carcinoma...
- Patients with psychiatric disorder, peripheral or central nerve system disease or any disorder, which compromises ability to give informed consent or...
- Patients who have myocardial infarction or congestive heart failure, or other serious cardiac disease.
- Patients who have used immunosuppressive drug or corticosteroids within 14 days.
- Patients who have other diseases which researchers.
See the full eligibility criteria
- Histologically documented Her-2 negative
- TNM stage: T1c, N1-N2；T2-4, N0-N2；any T, N3
- No distant metastatic disease
- Eastern Cooperative Oncology Group Performance Status: 0\~1
- HRR gene mutation: at least one pathogenic or likely pathogenic variant in germline or somatic BRCA1, BCRA2 and PALB2 genes, or in germline ATM, BARD1, BRIP1, CDK12, CHEK2, RAD51C, RAD51D genes.
- Patients who are pregnant or lactating at the time of randomization or refuse to contraception.
- Patients who have other malignant diseases within 2 years, except for cured skin basal cell carcinoma, breast carcinoma in situ or cervical carcinoma in situ
- Patients with psychiatric disorder, peripheral or central nerve system disease or any disorder, which compromises ability to give informed consent or participate in this study.
- Patients who have myocardial infarction or congestive heart failure, or other serious cardiac disease.
- Patients who have used immunosuppressive drug or corticosteroids within 14 days.
- Patients who have other diseases which researchers.
- Patients who allergy to any of the drugs in this trail.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.