Status:
NOT_YET_RECRUITING
Camrelizumab, Pirfenidone, and Chemotherapy in the Treatment of Advanced Triple-Negative Breast Cancer
Lead Sponsor:
Harbin Medical University
Conditions:
Breast Cancer
Triple Negative Breast Cancer (TNBC)
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is a prospective, single-arm, exploratory clinical study, planned to enroll 12 patients with advanced triple-negative breast cancer who have received first-line systemic treatment with immune che...
Eligibility Criteria
Inclusion
- Female, aged 18-70 years.
- Histologically confirmed recurrent/metastatic TNBC (ER-negative: IHC ER \<1%; PR-negative: IHC PR \<1%; HER2-negative: IHC -/+, or IHC ++ but FISH/CISH negative), with at least one measurable lesion per RECIST v1.1.
- ECOG performance status 0-2.
- Estimated life expectancy ≥3 months.
- Received first-line chemotherapy + PD-1/PD-L1 inhibitor for metastatic or locally advanced unresectable TNBC, with response of CR/PR or stable disease lasting ≥3 months. For neoadjuvant/adjuvant therapy, disease progression during treatment or within 6 months after completion will be considered as first-line failure.
- Adequate organ function (no transfusion, growth factor, or thrombopoietic agents within 2 weeks before screening):
- Hematology: ANC ≥1.5×10⁹/L; PLT ≥90×10⁹/L; Hb ≥90 g/L.
- Serum chemistry: TBIL ≤1.5×ULN; ALT and AST ≤1.5×ULN; ALP ≤2.5×ULN; BUN and Cr ≤1.5×ULN with creatinine clearance ≥50 mL/min (Cockcroft-Gault).
- TSH ≤ULN (if abnormal, T3 and T4 must be assessed; enrollment allowed if T3/T4 normal).
- Cardiac: LVEF ≥50% by echocardiography; 18-lead ECG with QTcF \<480 ms (female).
- Women of childbearing potential must have negative pregnancy test (serum or urine) within 7 days prior to enrollment and agree to use adequate contraception during treatment and for 4 months after last dose.
- Voluntarily signed informed consent and good compliance.
Exclusion
- Concurrent participation in another interventional cancer trial.
- Received other antitumor therapy within 14 days before first dose.
- Prior treatment with pirfenidone.
- Untreated active brain metastases or leptomeningeal disease.
- Major non-breast cancer surgery within 4 weeks prior to enrollment or incomplete recovery from such surgery.
- Active or history of autoimmune disease (except vitiligo, resolved childhood asthma without treatment in adulthood).
- Severe cardiac disease (e.g., heart failure with LVEF \<50%, uncontrolled arrhythmias, angina requiring medication, significant valvular disease, recent myocardial infarction, poorly controlled hypertension \>180/100 mmHg).
- Congenital or acquired immunodeficiency (e.g., HIV infection).
- Live vaccination within 4 weeks before or during study.
- Known allergy to study drugs or excipients.
- Severe concomitant disease or condition that may interfere with study participation per investigator judgment
Key Trial Info
Start Date :
September 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT07161791
Start Date
September 15 2025
End Date
December 31 2027
Last Update
September 9 2025
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