Actively Recruiting

Phase 2
Age: 18Years - 70Years
FEMALE
NCT06516289

Neoadjuvant Treatment of gBRCA-Mutated HER2-Negative Breast Cancer With HRS-1167 and Famitinib ± Camrelizumab

Led by Fudan University · Updated on 2024-12-12

130

Participants Needed

1

Research Sites

139 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Neoadjuvant Treatment of gBRCA-Mutated HER2-Negative Breast Cancer With HRS-1167 and Famitinib ± Camrelizumab

Who Can Participate

Age: 18Years - 70Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female patients aged 18 to 70 years
  • Histologically confirmed unilateral primary invasive breast cancer with specific tumor and lymph node stages (cT0-4, N1-3, M0 or cT≥3, N0, M0)
  • HER2-negative breast cancer defined by immunohistochemical or FISH testing
  • Pathogenic germline BRCA1 or BRCA2 mutation
  • At least one measurable lesion according to RECIST 1.1 criteria
  • ECOG performance status of 0 or 1
  • Adequate blood counts, liver, and kidney function without recent transfusions or stimulating factors
  • Left ventricular ejection fraction of 50% or higher
  • QT interval corrected by Fridericia method less than 470 msec on 12-lead ECG
  • Urinary protein less than 2+ or 24-hour protein quantification ≤1g if protein ≥2+
  • Willingness and ability to comply with study protocol including contraceptive measures and follow-up
  • Ability to understand follow-up procedures and provide informed consent
Not Eligible

You will not qualify if you...

  • Bilateral breast cancer or previous ductal or lobular carcinoma in situ
  • Previous invasive or metastatic breast cancer
  • Any malignant tumor diagnosed within 3 years before consent, except certain cured skin or cervical cancers
  • Systemic chemotherapy, targeted therapy, or radiotherapy within 3 years before consent
  • Prior treatment with VEGFR small molecule tyrosine kinase inhibitors (except bevacizumab) or PARP inhibitors
  • Stage IV breast cancer or inflammatory breast cancer
  • Uncontrolled heart diseases or hypertension (systolic ≥150 mmHg or diastolic ≥90 mmHg)
  • Recent significant bleeding events or arterial/venous thrombosis within specified timeframes
  • Difficulty swallowing tablets or abnormal gastrointestinal function affecting drug absorption
  • Recent use of certain enzyme inhibitors or inducers affecting drug metabolism
  • Severe or uncontrolled systemic diseases including infections, bleeding disorders, or serious medical conditions
  • Major surgery within 28 days before first dose or planned during the study
  • Unhealed wounds, ulcers, or fractures
  • Active hepatitis B or C infection
  • Known HIV infection
  • History of substance abuse or active psychiatric disorders requiring medication
  • Known allergy to study drugs or excipients
  • Pregnant or lactating women and those refusing contraception
  • Participation in other clinical trials within 30 days or within 5 drug half-lives
  • Investigator judgment of ineligibility for the study

AI-Screening

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Trial Site Locations

Total: 1 location

1

Breast cancer institute of Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, China, 200032

Actively Recruiting

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Research Team

Z

Zhi-Ming Shao, MD

CONTACT

X

Xi-Yu Liu, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

5

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