BridgeMD
New treatment option for BRCA-Mutated Breast Carcinoma
Official title Neoadjuvant Treatment of gBRCA-Mutated HER2-Negative Breast Cancer With HRS-1167 and Famitinib ± Camrelizumab
ClinicalTrials.gov ID: NCT06516289
What this study is testing
What is HRS-1167?
HRS-1167 is an investigational medicine, being studied as a potential treatment for brca-mutated breast carcinoma.
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 a prospective, open-label, multi-center, phase II clinical trial designed for HER2-negative breast cancer with pathogenic mutations in the germline gene (gBRCA1/2) that were indicated for neoadjuvant chemotherapy. The characteristics of this study are a precision treatment scheme without chemotherapy, the scheme of HRS-1167 combined with famitinib neoadjuvant therapy for patients with gBRCA mutations is explored, and the efficacy of combined immunotherapy is further explored according to the efficacy of the combination of the two drugs.
- 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 70, women only
You may be able to join if
- Age 18 to 70 years old, female.
- Patients with histologically confirmed unilateral primary invasive breast cancer who meet the criteria of cT0-4, N1-3, M0 or cT≥3, N0, M0...
- Patients with HER-2 negative disease. HER2-negative disease was defined as follows: disease whose HER-2 is 1+ or negative by immunohistochemical...
- Patients with pathogenic germline BRCA 1/2 mutation.
- According to the RECIST 1.1 criteria, there is at least one measurable objective lesion.
You likely can't join if
- Patients with any of the following were not enrolled in the study:
- Cancer-related history and treatment history: 1) Bilateral breast cancer; 2) Previous history of ductal carcinoma in situ (DCIS) or lobular carcinoma...
- Stage IV breast cancer according to the AJCC staging system, 8th edition.
- Inflammatory breast cancer or breast rupture.
- There are clinical symptoms or diseases of the heart that are not well controlled
- Hypertension that is not well controlled by antihypertensive medication: systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 90 mmHg has...
See the full eligibility criteria
Who can join
- Age 18 to 70 years old, female.
- Patients with histologically confirmed unilateral primary invasive breast cancer who meet the criteria of cT0-4, N1-3, M0 or cT≥3, N0, M0 (inflammatory breast cancer not included).
- Patients with HER-2 negative disease. HER2-negative disease was defined as follows: disease whose HER-2 is 1+ or negative by immunohistochemical (IHC), or fluorescence in situ hybridization (FISH) is negative if IHC is...
- Patients with pathogenic germline BRCA 1/2 mutation.
- According to the RECIST 1.1 criteria, there is at least one measurable objective lesion.
- Eastern Cooperative Oncology Group (ECOG) performance score 0-1.
- Appropriate haematological, hepatic and renal function (no blood transfusion or hematopoietic stimulating factors within 14 days): 1) Absolute number of neutrophils (ANC) ≥ 1.5 x 10\^9/L; 2) Platelets ≥ 100 x 10\^9/L...
- Left ventricular ejection fraction (LVEF) ≥ 50%.
- 12-lead ECG: QT interval corrected by Fridericia method (QTcF) \< 470 msec.
- Urine test: urinary protein \< 2+; If urinary protein ≥ 2+, 24-hour urinary protein quantification must show protein ≤1g.
- Subject is willing and able to comply with the protocol (including contraceptive measures) for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
- With good compliance with the planned treatment, are able to understand the follow-up procedures of this study and sigh the informed consent form.
What rules you out
- Patients with any of the following were not enrolled in the study:
- Cancer-related history and treatment history: 1) Bilateral breast cancer; 2) Previous history of ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS); 3) Previous history of invasive or metastatic breast...
- Stage IV breast cancer according to the AJCC staging system, 8th edition.
- Inflammatory breast cancer or breast rupture.
- There are clinical symptoms or diseases of the heart that are not well controlled
- Hypertension that is not well controlled by antihypertensive medication: systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 90 mmHg has a history of hypertensive crisis or hypertensive encephalopathy.
- NCI-CTCAE v5.0 grade ≥2 bleeding events occurred within 4 weeks before the first medication, including but not limited to hemoptysis (single episode of hemoptysis volume ≥ 2mL), vaginal bleeding, gastrointestinal...
- Excessive arterial/venous thrombosis events occurred within 6 months before the first medication, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep...
- Inability to swallow tablets normally or abnormal gastrointestinal function, which may affect drug absorption as judged by the researcher;
- Receipt of a strong inhibitor of CYP3A4, CYP2D6, P-gp, or BCRP from the date of first dose \<5 times of drug half-lives or 14 days; The interval between receiving treatment with the above enzyme strong inducers and the...
- Evidence of any disease as judged by the investigator (e.g., severe or uncontrolled systemic disease, including severe systemic infection, uncontrolled hypertension, renal transplantation and active bleeding disease...
- Have undergone major surgery other than invasive diagnostic procedures, peripherally inserted central catheter (PICC) procedures, or pathological biopsy within 28 days prior to the first dose, or are expected to undergo...
- Unhealed wounds, ulcers, or fractures;
- Active hepatitis B (defined as hepatitis B surface antigen [HBsAg] positive and HBV-DNA ≥500IU/ml);
- Hepatitis C infection (defined as a positive test for hepatitis C virus antibody [HCV-Ab] and an HCV-RNA test higher than the lower limit of the assay);
- Known history of human immunodeficiency virus (HIV) infection;
- Known history of psychotropic substance abuse, alcohol or drug abuse;
- Active psychiatric disorders (schizophrenia, major depressive disorder, bipolar disorder, etc.) and depression being treated with antidepressants were not exclusion criteria.
- Patients with known allergy or intolerance to the study drug or its excipents;
- Patients of reproductive age who are pregnant or lactating, and who refuse to use appropriate contraception during the course of the trial;
- Participated in other trial studies within 30 days before the first dose of the study drug, or not more than 5 half-lives since the last dose of the study drug;
- Patients judged by the investigator to be ineligible for the study.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, 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 female, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, 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.