Camrelizumab Plus Risedronate and Chemotherapy for Triple-Negative Breast Cancer: An Exploratory Clinical Study on Mechanisms and Efficacy

NCT07471815 | Active Not Recruiting Phase 2

• 1 other identifier: SHR-1210-HLJ-260201
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Treatment of triple-negative breast cancer (TNBC) remains a significant challenge. Although immune checkpoint inhibitors combined with chemotherapy have achieved breakthroughs, drug resistance persists, leaving clinical needs unmet. Bisphosphonates target the FDPS/mevalonate pathway, not only directly inhibiting tumors but also remodeling the immune microenvironment, positioning them as a potential strategy to reverse immune resistance. Therefore, this exploratory study of camrelizumab combined with risedronate sodium and chemotherapy aims to generate synergistic anti-tumor effects through the dual action of immune checkpoint blockade and metabolic-immune microenvironment remodeling. The goal is to overcome resistance, improve the objective response rate, and ultimately enhance the long-term survival prognosis for patients with TNBC.

Conditions

Breast Cancer Triple Negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

• ORR

  Objective Response Rate

  At the end of every 2 Cycles (each cycle is 21 days), From first treatment Cycle until achieving complete response (CR) or response (PR) per RECIST v1.1, assessed up to 1 year, defined as the proportion of patients achieving complete response

Secondary Outcomes (7)

• Incidence of adverse events of any grade

  Safety follow-up will be conducted from the first dose until the end of treatment. Adverse events occurring during this period will be recorded, with a maximum assessment period of 2 years.

• OS

  Refers to the time from randomization to death due to any cause, with a maximum assessment period of 2 years.

• 6-PFS Rate

  The proportion of patients who have not experienced tumor progression or death from any cause by 6 months from the start of first treatment, with a maximum assessment period of 6 months.

• DOR

  Refers to the time from the first assessment of CR or PR to the first assessment of disease progression (PD) or death from any cause. The assessment period is up to 2 years.

• DCR

  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.

Other Outcomes (1)

• Mechanism Exploration

  The mechanism of Camrelizumab combined with Risedronate Sodium and chemotherapy, with a maximum follow-up of up to 2 years.

Study Arms (1)

Treatment Group

EXPERIMENTAL

Camrelizumab + Risedronate Sodium + Chemotherapy

Drug: Camrelizumab + Risedronate Sodium + Chemotherapy

Interventions

Camrelizumab + Risedronate Sodium + Chemotherapy DRUG

Camrelizumab: 200 mg, intravenous drip, administered in line with the chemotherapy regimen cycles. Risedronate Sodium: Oral administration. Should be taken while in an upright position at least 30 minutes before the first food or drink of the day, swallowed with a full glass of plain water (approximately 200 ml). Patients should not lie down for at least 30 minutes after taking. Dosage is one 5 mg tablet once daily. Chemotherapy regimens are selected by the physician and include, but are not limited to: TAC, TP-AC, AC-T, etc. A total of 6 treatment cycles are planned; the subsequent regimen will be chosen by the investigator.

Treatment Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients aged ≥ 18 years and ≤ 70 years.
• Histopathologically confirmed triple-negative breast cancer: Immunohistochemistry (IHC) shows estrogen receptor (ER) and progesterone receptor (PR) are both negative (i.e., positively stained tumor cells account for \<10% of all tumor cells); IHC shows HER2 negative: test result is 0/1+; if the test result is 2+, in situ hybridization (ISH) must show a HER2/CEP17 ratio \< 2.0 or HER2 gene copy number \< 4.
• Presence of measurable tumor lesions (meeting RECIST 1.1 criteria).
• ECOG performance status score of 0-2.
• Life expectancy of no less than 3 months.
• Adequate major organ function meeting the following criteria (no blood transfusions, no use of leukocyte- or platelet-raising drugs within 2 weeks prior to screening):
• (1) Hematology requirements: ANC ≥ 1.5 × 10⁹/L; PLT ≥ 90 × 10⁹/L; Hb ≥ 90 g/L. (2) Biochemistry requirements: TBIL ≤ 1.5 × upper limit of normal (ULN); ALT and AST ≤ 1.5 × ULN; Alkaline phosphatase ≤ 2.5 × ULN; BUN and Cr ≤ 1.5 × ULN and creatinine clearance ≥ 50 mL/min (by Cockcroft-Gault formula).
• (3) Thyroid-stimulating hormone (TSH) ≤ ULN (if abnormal, T3 and T4 levels should be checked; patients with normal T3 and T4 levels can be enrolled).
• (4) Cardiac color Doppler ultrasound and echocardiography: Left ventricular ejection fraction (LVEF) ≥ 50%.
• (5) 18-lead ECG: Fridericia-corrected QT interval (QTcF) \< 480 ms for females.
• Women of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days before enrollment and voluntarily agree to use adequate contraception during the observation period and for 4 months after the last dose of the study drug.
• Voluntary participation, signed informed consent, and good compliance.

You may not qualify if:

• Concurrently receiving anti-tumor therapy in another clinical trial.
• Received other anti-tumor therapy within 14 days prior to the first dose.
• Underwent major surgery unrelated to breast cancer within 4 weeks before enrollment, or has not fully recovered from such surgery.
• Patients with any active autoimmune disease or a history of autoimmune disease (such as, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; patients with vitiligo or childhood asthma that has completely resolved and requires no intervention in adulthood may be included; patients requiring bronchodilators for asthma management cannot be included).
• Severe cardiac disease or discomfort, including but not limited to: history of heart failure or systolic dysfunction (LVEF \< 50%); high-risk uncontrolled arrhythmias, such as atrial tachycardia, resting heart rate \> 100 bpm, significant ventricular arrhythmias (e.g., ventricular tachycardia), or higher-degree atrioventricular block (i.e., Mobitz II second-degree or third-degree AV block); angina requiring anti-anginal medication; clinically significant valvular heart disease; ECG evidence of transmural myocardial infarction; poorly controlled hypertension (systolic blood pressure \> 180 mmHg and/or diastolic blood pressure \> 100 mmHg).
• Patients with congenital or acquired immunodeficiency (e.g., HIV infection).
• Received a live vaccine within 4 weeks prior to study medication or plans to receive one during the study.
• Inability to swallow tablets, malabsorption syndrome, or any condition affecting gastrointestinal absorption.
• Known history of allergy to any component of the study drugs in this protocol.
• Patients with hypocalcemia.
• Patients unable to maintain a standing or sitting upright position for 30 minutes.
• Presence of severe concomitant diseases or other comorbidities that would interfere with the planned treatment, or any other condition deemed by the investigator to make the patient unsuitable for participation in this study.

Sponsors & Collaborators

• Harbin Medical University: lead

Study Sites (1)

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 158100, China

Location

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

camrelizumab; Risedronic Acid; Drug Therapy

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 13, 2026
• Study Start: March 4, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2029
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)