Experimental Triple-Drug cocktail targets Hard-to-Treat breast cancer
NCT ID NCT07161791
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This early-phase study will test a combination of three drugs—camrelizumab (an immunotherapy), pirfenidone (an anti-fibrotic drug), and standard chemotherapy—in 12 women with advanced triple-negative breast cancer that has already been treated with immunotherapy. The goal is to see if the combination can shrink tumors or control the disease. The trial is not yet recruiting.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- camrelizumab (immune therapy), pirfenidone (anti-fibrotic drug), and chemotherapy (paclitaxel or capecitabine)
- What this could lead to
- If it works, this combination could offer a new treatment option for advanced triple-negative breast cancer that has stopped responding to initial therapy.
- What could go wrong
- This is a very small, early-phase trial with only 12 people, so results may not apply broadly. The combination may cause significant side effects or fail to improve outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2025
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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