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

Plain English Summary

A Single-Arm, Single-Center, Phase II Clinical Study of Camrelizumab Combined With Radiochemotherapy as Neoadjuvant Therapy for Early-Stage Triple-Negative Breast Cancer is a Not Applicable clinical trial sponsored by Tianjin Medical University Cancer Institute and Hospital studying TNBC. This study tests a combination of camrelizumab (an immunotherapy drug), chemotherapy, and radiation therapy. It is for women with early-stage triple-negative breast cancer (TNBC) who have not yet received treatment. Participation involves receiving the combination therapy for 12 weeks, followed by surgery, and potentially more treatment if needed. Alternatives may include standard chemotherapy, radiation, or surgery alone, depending on the specific cancer stage and type. The trial aims to enroll 43 participants.

Official 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-la

Who Can Participate

Here is what you need to know about eligibility for this trial. Women aged 18-75 with newly diagnosed, untreated early-stage TNBC. Patients must have specific tumor characteristics (ER-, PR-, HER2-) and measurable disease. Exclusion criteria include metastatic or inflammatory breast cancer, prior cancer treatments, and certain autoimmune or severe health conditions. This trial is studying TNBC, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcome measures whether the tumor is completely eliminated (pathological complete response) after the neoadjuvant therapy, meaning no cancer cells are found in the breast or lymph nodes d The specific primary outcome measures are: pCR(ypT0/Tis ypN0) (through study completion, an average of 1 year.). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial aims to improve treatment outcomes for early-stage triple-negative breast cancer, a particularly aggressive form of the disease with limited treatment options. This research targets TNBC, where improved treatment options are needed.

Investor Insight

This trial targets a significant unmet need in early-stage TNBC, a market with a high demand for more effective therapies, suggesting potential for a new treatment combination if successful.

Is This Trial Right for Me?

Ask your doctor about the specific drugs used, potential side effects, and how the treatment will be monitored. Participation involves regular clinic visits for infusions, radiation, imaging scans, and blood tests over several months, followed by surgery and ongoing follow-up. The trial is being conducted at multiple sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NA
• Model: SINGLE_GROUP
• Masking: NONE
• Enrollment: 43 participants

Interventions

• DRUG: treatment group — * Albumin-bound paclitaxel; * Carboplatin; * Camrelizumab injection; * Stereotactic Body Radiotherapy; * Epirubicin; * Cyclophosphamide; * Surgery;

Primary Outcomes

• pCR(ypT0/Tis ypN0) (through study completion, an average of 1 year.)

Secondary Outcomes

• PCR rate among ethnic minority populations (through study completion, an average of 1 year.)
• pCR rates based on different definitions of pCR (ypT0/is ypN0, ypT0 ypN0/+, ypT0/is ypN0/+, pCR with no restrictions on ypT and ypN0) (through study completion, an average of 1 year.)
• Objective Response Rate (ORR) (18 to 24 weeks after the first dose)
• Breast-conserving surgery rate (18 to 24 weeks after the first dose)
• Disease-free survival(DFS) (From the first dose until disease progression/recurrence/death, or up to 3 years after the first dose, whichever occurs first)

Full Eligibility Criteria

Inclusion Criteria:

* Female patients aged ≥18 years and ≤75 years with treatment-naive breast cancer;
* Histopathologically confirmed early-stage triple-negative invasive breast cancer as defined by the latest ASCO/CAP guidelines, meeting all of the following criteria: Pathological subtype must be triple-negative, specifically: ER-negative: IHC \<1%, PR-negative: IHC \<1%, HER2-negative: IHC 0/1+ or IHC 2+ but ISH-negative;
* Primary triple-negative breast cancer patients with clinical staging cT1c-T4d and any cN status;
* Center-assessed Ki67 and sTIL values;
* Expected survival ≥ 3 months;
* At least one measurable lesion present per RECIST 1.1 criteria;
* Organ function levels must meet the following requirements: 1) Complete blood count (CBC) neutrophil count (ANC) ≥ 1.5 × 10⁹/L (no hematopoietic growth factor use within 14 days prior to first study dose); White blood cell count (WBC) ≥3.0×10⁹/L and ≤15×10⁹/L; lymphocyte count (LC) ≥0.5×10⁹/L; platelet count (PLT) ≥100×10⁹/L (no blood transfusion within 14 days prior to first study dose) Hemoglobin (Hb) ≥90 g/L; 2) Blood Biochemistry: TBIL ≤1.5×ULN; ALT and AST ≤2.5×ULN; ALP ≤2.5×ULN; BUN and Cr ≤1.5×ULN with creatinine clearance ≥50 mL/min (Cockcroft-Gault formula); INR and APTT ≤ 1.5×ULN (without anticoagulant therapy); Thyroid-stimulating hormone (TSH) ≤ upper limit of normal (ULN); if abnormal, assess T3 and T4 levels; inclusion permitted if T3 and T4 levels are normal; 3) Cardiac function: Echocardiogram: LVEF ≥ 50%; Lead ECG: QT interval, females \< 470 ms.
* Contraception: Female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours prior to first dosing and agree to use a medically approved highly effective contraceptive method during the study and for 90 days after the last study drug administration. The investigator or designated personnel will select an appropriate contraceptive method for the subject and her partner from the options below after consultation, confirming the subject understands how to use it correctly and consistently. At the timepoints listed in the protocol, the investigator will notify the subject of the need for continuous, correct contraception. Additionally, the subject must be aware that they must immediately notify the investigator if they discontinue the selected contraceptive method or if they suspect or confirm pregnancy. A highly effective contraceptive method is one that, when used correctly and consistently alone or in combination with other methods, has an annual failure rate of less than 1%. These include the following: 1) Correct placement of an intrauterine device (IUD). 2) Condoms used in combination with a spermicide (i.e., foam, gel, film, cream, or suppository). 3) Bilateral tubal ligation/bilateral salpingectomy or bilateral tubal occlusion surgery (occlusion confirmed effective by relevant instrumentation). 4) Male vasectomy.
* Voluntarily enrolled in this study, signed informed consent, demonstrated good compliance, and agreed to participate in follow-up visits.

Exclusion Criteria:

* Tumor-Related Symptoms and Treatments

  1. Patients with metastatic breast cancer or bilateral breast cancer;
  2. Patients with inflammatory breast cancer;
  3. 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;
  4. Previous treatment with PD-1/PD-L1 antibodies, CTLA-4 antibodies, or other PD-1/PD-L1 inhibitors;
* Concurrent Diseases/Medical History

  1. 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.
  2. 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);
  3. Subjects with any known or suspected autoimmune disease, except:

Hypothyroidism due to autoimmune thyroiditis requiring only hormone replacement therapy; Subjects with stable, well-controlled type 1 diabetes mellitus; 4) Presence of interstitial lung disease, non-infectious pneumonia, or uncontrolled systemic disease (e.g., diabetes mellitus, pulmonary fibrosis, acute pneumonia); 5) History of live attenuated vaccine administration within 28 days prior to first study dose or anticipated live attenuated vaccine administration during the study period; 6) Human Immunodeficiency Virus (HIV) infection or known Acquired Immunodeficiency Syndrome (AIDS); Hepatitis B Virus Surface Antigen (HBsAg) positive, or Hepatitis B Core Antibody (HBcAb) positive followed by positive HBV-DNA test (HBV-DNA testing only for HBsAg nega

Frequently Asked Questions

Related Conditions

• Triple-Negative Breast Cancer
• Early-Stage Breast Cancer
• Neoadjuvant Therapy
• Immunotherapy
• Chemotherapy
• Radiotherapy
• Breast Cancer
• Oncology
• Cancer Treatment
• Targeted Therapy

More TNBC Trials

View all TNBC clinical trials