Not Yet RecruitingNot Applicable

A Single-Arm, Single-Center, Phase II Clinical Study of Camrelizumab Combined With Radiochemotherapy as Neoadjuvant Therapy for Early-Stage Triple-Negative Breast Cancer

43 participantsStarted 2026-03-25

Plain-language summary

Camrelizumab + Chemoradiotherapy for Early TNBC Sponsor/Leading Center: Tianjin Medical University Cancer Institute and Hospital Study Type: Single-arm, single-center, Phase Ⅱ clinical study Planned Enrollment: 43 patients Eligible Population 18-75-year-old female patients with newly diagnosed, untreated early invasive triple-negative breast cancer (TNBC) (ER-/PR-/HER2- per ASCO/CAP guidelines), clinical stage cT1c-T4d (any cN); central assessment of Ki67 and sTIL values, at least one measurable lesion (RECIST 1.1), normal major organ function, expected survival ≥3 months; negative pregnancy test (women of childbearing potential) with agreement to effective contraception; signed informed consent and good compliance. Exclusion: Metastatic/bilateral/inflammatory TNBC; prior anti-tumor/PD-1/PD-L1 treatment within 12 months; active other malignancies, autoimmune diseases, interstitial lung disease, uncontrolled severe infections/heart disease; pregnancy/lactation; allergy to study drugs. Study Design Treatment Regimen (Neoadjuvant + Individualized Follow-up) All patients receive the same combined therapy, followed by surgery (with extended treatment for non-responders): 12-week core neoadjuvant treatment: Camrelizumab (200mg IV, Q3W) + nab-paclitaxel (100mg/m² IV, weekly) + carboplatin (AUC=1 IV, weekly) + SBRT (10Gy × 2 sessions, on the 3rd day after chemotherapy in Week 3 and 6). Post-12-week evaluation \& treatment: Clinical responders: Undergo surgery within 3 weeks. Clinical non-responders: Continue with 12-week EC regimen (epirubicin 80mg/m² + cyclophosphamide 600mg/m², IV Q3W, 4 cycles) + camrelizumab, then surgery within 3 weeks. Study Procedures Screening (≤28 days): Complete imaging, laboratory and physical examinations to confirm eligibility. Treatment period: Scheduled combined therapy with regular efficacy assessments (breast imaging every 2 cycles) and safety monitoring. Follow-up: Mandatory surgery after treatment; 90-day safety follow-up post-last dose, and long-term survival follow-up (q3m for Year 1, q6m thereafter) for 5 years. Primary Outcome Pathological complete response (pCR, defined as ypT0/Tis ypN0: no residual invasive cancer in resected breast and sampled lymph nodes).

Who can participate

Age range

18 Years – 75 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. Patients with metastatic breast cancer or bilateral breast cancer;
. Patients with inflammatory breast cancer;
. Received any antitumor therapy within 12 months prior to signing the informed consent form, including chemotherapy, targeted therapy, radiotherapy, endocrine therapy, immunotherapy, biological therapy, or tumor embolization;
. Previous treatment with PD-1/PD-L1 antibodies, CTLA-4 antibodies, or other PD-1/PD-L1 inhibitors;
. Active malignancies within 5 years prior to or concurrent with informed consent. Patients with cured localized tumors such as basal cell carcinoma, squamous cell carcinoma of the skin, superficial bladder cancer, or cervical carcinoma in situ may be eligible.
. Major non-breast cancer-related surgical procedures within 4 weeks prior to enrollment, or patients not yet fully recovered from such procedures (tissue biopsies for diagnostic purposes and peripheral intravenous catheter placement for central venous access \[PICC\] are permitted);

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

pCR(ypT0/Tis ypN0)

Timeframe: through study completion, an average of 1 year.

Trial details

NCT IDNCT07491822

SponsorTianjin Medical University Cancer Institute and Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-09-15

Contact for this trial

Yongsheng jia Tianjin Medical University Cancer Institute

13302019383 yongshengjia@tjmuch.com

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