Breast Cancer Triple Negative Breast CancerPhase 2NCT07471815

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

A Phase 2 study testing Camrelizumab + Risedronate Sodium + Chemotherapy in people with Breast Cancer Triple Negative Breast Cancer, run by Harbin Medical University at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 to 70 years, women only
Conditions the study is for: Breast Cancer Triple Negative Breast Cancer
What is being tested?: Camrelizumab + Risedronate Sodium + 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: 30 participants
Where: 1 siteChina
Study dates: 4 Mar 2026to 31 Mar 2029
Phase: Phase 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 to 70 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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):

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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).
Thyroid-stimulating hormone (TSH) ≤ ULN (if abnormal, T3 and T4 levels should be checked; patients with normal T3 and T4 levels can be enrolled).
Cardiac color Doppler ultrasound and echocardiography: Left ventricular ejection fraction (LVEF) ≥ 50%.
18-lead ECG: Fridericia-corrected QT interval (QTcF) < 480 ms for females.
7.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.
8.Voluntary participation, signed informed consent, and good compliance.

Who cannot join

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).

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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.

Trial locations and contacts

1 site in 1 country.

China1 site

Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 158100

Other trials in China

About this study

Official title: Mechanisms and Efficacy of Camrelizumab Plus Risedronate and Chemotherapy in Triple-Negative Breast Cancer: An Exploratory Clinical Study

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
Being tested: Camrelizumab + Risedronate Sodium + Chemotherapy
Medical subject headings: Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Camrelizumab + Risedronate Sodium + ChemotherapyDrug
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.

Study groups in NCT07471815
Study group	Role	What they receive
Treatment Group	Experimental	Camrelizumab + Risedronate Sodium + Chemotherapy Receives: Drug: Camrelizumab + Risedronate Sodium + Chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

ORR
Objective Response Rate
Measured: 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
Incidence of adverse events (AEs) and serious adverse events (SAEs) of any grade, assessed according to NCI-CTCAE version 6.0 criteria.
Measured: 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
Overall Survival
Measured: Refers to the time from randomization to death due to any cause, with a maximum assessment period of 2 years.
6-PFS Rate
6-Month Progression-Free Survival Rate
Measured: 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
Duration of Response
Measured: 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
Disease Control Rate: Refers to the percentage of patients with evaluable cases who achieve Complete Response (CR), Partial Response (PR), or Stable Disease (SD) following treatment.
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.
Incidence of new bone metastases
Refers to the ratio of the number of new cases with bone metastases to the total number of cases in the same population during the corresponding period.
Measured: Starting from the first dose, regular imaging follow-ups will be conducted to monitor for the occurrence of bone metastases, continuing until 2 years.
BMD
Bone Mineral Density
Measured: A key indicator for measuring bone strength, reflecting the mineral content (mainly calcium, phosphorus, etc.) per unit volume or unit area of bone. Assessments will be conducted once every three months for up to 2 year.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Mar 202631 Mar 2029

First posted13 Mar 2026
Study start4 Mar 2026
Primary completion31 Mar 2028 (estimated)
Study completion31 Mar 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Breast Cancer Triple Negative 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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 30 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07471815
Sponsor's protocol ID: SHR-1210-HLJ-260201
Status last verified: Mar 2026
First submitted: 10 Mar 2026
Last updated: 13 Mar 2026
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 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Mechanisms and Efficacy of Camrelizumab Plus Risedronate and Chemotherapy in Triple-Negative Breast Cancer: An Exploratory Clinical Study
ClinicalTrials.gov ID: NCT07471815
Acronym / sponsor ID: SHR-1210-HLJ-260201
Conditions: Breast Cancer Triple Negative Breast Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 30 participants (estimated)
Lead sponsor: Harbin Medical UniversityUniversity, hospital or other
Study start: 4 Mar 2026 (actual)
Primary completion: 31 Mar 2028 (estimated)
Study completion: 31 Mar 2029 (estimated)
First posted: 13 Mar 2026 (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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment Group	Experimental	Drug: Camrelizumab + Risedronate Sodium + ChemotherapyCamrelizumab + Risedronate Sodium + Chemotherapy

Who may qualify

Ages: 18 to 70 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

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.

Key exclusion criteria (12 listed)

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).

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 + Risedronate Sodium + ChemotherapyCamrelizumab: 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.	Drug	Treatment Group

Primary outcome

ORR
Time frame: 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
Objective Response Rate

7 secondary outcomes

Incidence of adverse events of any grade
Time frame: 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
Time frame: Refers to the time from randomization to death due to any cause, with a maximum assessment period of 2 years.
6-PFS Rate
Time frame: 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
Time frame: 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
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.
Incidence of new bone metastases
Time frame: Starting from the first dose, regular imaging follow-ups will be conducted to monitor for the occurrence of bone metastases, continuing until 2 years.
BMD
Time frame: A key indicator for measuring bone strength, reflecting the mineral content (mainly calcium, phosphorus, etc.) per unit volume or unit area of bone. Assessments will be conducted once every three months for up to 2 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 13 Mar 2026.
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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Camrelizumab + Risedronate Sodium + Chemotherapy in people with Breast Cancer Triple Negative Breast Cancer, run by Harbin Medical University at 1 site in China.

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 12 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: under way, not looking for participants, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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 phase mean?

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07471815.

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 13 Mar 2026.