Breast CancerPhase 1/2NCT07161791
Camrelizumab, Pirfenidone, and Chemotherapy in the Treatment of Advanced Triple-Negative Breast Cancer
A Phase 1/2 study testing Camrelizumab Combined With Pirfenidone and Chemotherapy in people with Breast Cancer and Triple Negative Breast Cancer (TNBC), run by Harbin Medical University.
Trial 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 checkpoint inhibitors. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Triple Negative Breast Cancer (TNBC)
- What is being tested?
- Camrelizumab Combined With Pirfenidone and Chemotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2025to 31 Dec 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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):
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- 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.
Who cannot join
- 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).
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Exploratory Clinical Study of Camrelizumab Combined With Pirfenidone and Chemotherapy in the Treatment of Advanced Triple-Negative Breast Cancer
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 checkpoint inhibitors. The treatment regimen will continue until disease progression, intolerable toxicity, withdrawal of informed consent, or investigator's judgment that treatment must be terminated. Imaging assessment will be performed according to RECIST 1.1 criteria, with the research center's assessment results as the final outcome. Subjects who discontinue treatment will enter the follow-up period: 1) Safety follow-up until 30 days after the last dose; 2) Subjects who discontinue treatment for reasons other than progression disease (PD) or death will undergo efficacy follow-up until disease progression, initiation of other anti-tumor drugs, or death, whichever comes first; 3) All subjects will enter the trial period upon enrollment and receive camrelizumab combined with pirfenidone and chemotherapy.
- Being tested
- Camrelizumab Combined With Pirfenidone and Chemotherapy
- Keywords
- Breast Cancer, TNBC, Immunotherapy
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Camrelizumab Combined With Pirfenidone and ChemotherapyDrug
Treatment Regimen:
Camrelizumab: 200 mg intravenous (IV) every 3 weeks (q3w). Pirfenidone: 200 mg three times daily (tid), escalated to 600 mg tid based on tolerability.
Chemotherapy: Investigator's choice of standard regimens (e.g., paclitaxel 175 mg/m² IV q3w or capecitabine 1000 mg/m² orally bid on days 1-14 of a 21-day cycle).
| Study group | Role | What they receive |
|---|---|---|
| Camrelizumab Combined With Pirfenidone and Chemotherapy Treatment Group | Experimental | Study Population:
Patients with recurrent or metastatic triple-negative breast cancer (TNBC) who have progressed after first-line systemic therapy with immune checkpoint inhibitors (anti-PD-1/PD-L1).
Treatment Regimen:
Camrelizumab: 200 mg intravenous (IV) every 3 weeks (q3w). Pirfenidone: 200 mg three times daily (tid), escalated to 600 mg tid based on tolerability.
Chemotherapy: Investigator's choice of standard regimens (e.g., paclitaxel 175 mg/m² IV q3w or capecitabine 1000 mg/m² orally bid on days 1-14 of a 21-day cycle). Receives: Drug: Camrelizumab Combined With Pirfenidone and Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR（Objective Response Rate）
defined as the proportion of patients achieving complete response (CR) or partial response (PR) per RECIST v1.1.
Measured: At the end of every 2 Cycles (each cycle is 21 days) , From first treatment Cycle until achieving complete response (CR) or partialresponse (PR) per RECIST v1.1.], assessed up to 1 year.
Secondary outcomes (4)
DCR（Disease Control Rate）
Proportion of patients with CR, PR, or stable disease (SD) ≥6 months
Measured: Patients undergo imaging evaluation in every 2 cycles（each cycyle is 21 days）until achieving SD per RECIST v1.1 or through study completion, assessed up to 1 year.
CBR（Clinical Benefit Rate）
Proportion of patients with CR, PR, or SD ≥6 months
Measured: through study completion, an average of 1 year".
PFS（Progression-Free Survival）
Time from enrollment to disease progression or death
Measured: up to 1 year
OS（Overall Survival）
Time from enrollment to death from any cause
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start15 Sep 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Treatment Regimen: Camrelizumab: 200 mg intravenous (IV) every 3 weeks (q3w). Pirfenidone: 200 mg three times daily (tid), escalated to 600 mg tid based on tolerability. Chemotherapy: Investigator's choice of standard regimens (e.g., paclitaxel 175 mg/m² IV q3w or capecitabine 1000 mg/m² orally bid on days 1-14 of a 21-day cycle).
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tong Liu, Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07161791
- Sponsor's protocol ID
- OBU-BC-II-271
- Status last verified
- Aug 2025
- First submitted
- 15 Aug 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Clinical Study of Camrelizumab Combined With Pirfenidone and Chemotherapy in the Treatment of Advanced Triple-Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT07161791
- Acronym / sponsor ID
- OBU-BC-II-271
- Keywords
- Breast Cancer, TNBC, Immunotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Harbin Medical UniversityUniversity, hospital or other
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 checkpoint inhibitors. The treatment regimen will continue until disease progression, intolerable toxicity, withdrawal of informed consent, or investigator's judgment that treatment must be terminated. Imaging assessment will be performed according to RECIST 1.1 criteria, with the research center's assessment results as the final outcome. Subjects who discontinue treatment will enter the follow-up period: 1) Safety follow-up until 30 days after the last dose; 2) Subjects who discontinue treatment for reasons other than progression disease (PD) or death will undergo efficacy follow-up until disease progression, initiation of other anti-tumor drugs, or death, whichever comes first; 3) All subjects will enter the trial period upon enrollment and receive camrelizumab combined with pirfenidone and chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Treatment Regimen: Camrelizumab: 200 mg intravenous (IV) every 3 weeks (q3w). Pirfenidone: 200 mg three times daily (tid), escalated to 600 mg tid based on tolerability. Chemotherapy: Investigator's choice of standard regimens (e.g., paclitaxel 175 mg/m² IV q3w or capecitabine 1000 mg/m² orally bid on days 1-14 of a 21-day cycle).
| Arm | Type | Receives |
|---|---|---|
| Camrelizumab Combined With Pirfenidone and Chemotherapy Treatment Group | Experimental | Drug: Camrelizumab Combined With Pirfenidone and ChemotherapyStudy Population: Patients with recurrent or metastatic triple-negative breast cancer (TNBC) who have progressed after first-line systemic therapy with immune checkpoint inhibitors (anti-PD-1/PD-L1). Treatment Regimen: Camrelizumab: 200 mg intravenous (IV) every 3 weeks (q3w). Pirfenidone: 200 mg three times daily (tid), escalated to 600 mg tid based on tolerability. Chemotherapy: Investigator's choice of standard regimens (e.g., paclitaxel 175 mg/m² IV q3w or capecitabine 1000 mg/m² orally bid on days 1-14 of a 21-day cycle). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Camrelizumab Combined With Pirfenidone and ChemotherapyTreatment Regimen: Camrelizumab: 200 mg intravenous (IV) every 3 weeks (q3w). Pirfenidone: 200 mg three times daily (tid), escalated to 600 mg tid based on tolerability. Chemotherapy: Investigator's choice of standard regimens (e.g., paclitaxel 175 mg/m² IV q3w or capecitabine 1000 mg/m² orally bid on days 1-14 of a 21-day cycle). | Drug | Camrelizumab Combined With Pirfenidone and Chemotherapy Treatment Group |
Primary outcome
ORR（Objective Response Rate）
Time frame: At the end of every 2 Cycles (each cycle is 21 days) , From first treatment Cycle until achieving complete response (CR) or partialresponse (PR) per RECIST v1.1.], assessed up to 1 year.
defined as the proportion of patients achieving complete response (CR) or partial response (PR) per RECIST v1.1.
4 secondary outcomes
DCR（Disease Control Rate）
Time frame: Patients undergo imaging evaluation in every 2 cycles（each cycyle is 21 days）until achieving SD per RECIST v1.1 or through study completion, assessed up to 1 year.
CBR（Clinical Benefit Rate）
Time frame: through study completion, an average of 1 year".
PFS（Progression-Free Survival）
Time frame: up to 1 year
OS（Overall Survival）
Time frame: up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Camrelizumab Combined With Pirfenidone and Chemotherapy in people with Breast Cancer and Triple Negative Breast Cancer (TNBC), run by Harbin Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huang Doctor (0451-86298091, huangfx@hrbmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR（Objective Response Rate） (time frame: At the end of every 2 Cycles (each cycle is 21 days) , From first treatment Cycle until achieving complete response (CR) or partialresponse (PR) per RECIST v1.1.], assessed up to 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.