BRCA-Mutated Breast CarcinomaPhase 2NCT06516289
Neoadjuvant Treatment of gBRCA-Mutated HER2-Negative Breast Cancer With HRS-1167 and Famitinib ± Camrelizumab
A Phase 2 study testing HRS-1167, Famitinib and Camrelizumab in people with BRCA-Mutated Breast Carcinoma and HER2-negative Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
This study is a prospective, open-label, multi-center, phase II clinical trial designed for HER2-negative breast cancer with pathogenic mutations in the germline gene (gBRCA1/2) that were indicated for neoadjuvant chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- BRCA-Mutated Breast Carcinoma, HER2-negative Breast Cancer
- What is being tested?
- HRS-1167, Famitinib and Camrelizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2024to Jun 2027
- 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
- Age 18 to 70 years old, female.
- Patients with histologically confirmed unilateral primary invasive breast cancer who meet the criteria of cT0-4, N1-3, M0 or cT≥3, N0, M0 (inflammatory breast cancer not included).
- Patients with HER-2 negative disease. HER2-negative disease was defined as follows: disease whose HER-2 is 1+ or negative by immunohistochemical (IHC), or fluorescence in situ hybridization (FISH) is negative if IHC is 2+.
- Patients with pathogenic germline BRCA 1/2 mutation.
- According to the RECIST 1.1 criteria, there is at least one measurable objective lesion.
- Eastern Cooperative Oncology Group (ECOG) performance score 0-1.
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- Appropriate haematological, hepatic and renal function (no blood transfusion or hematopoietic stimulating factors within 14 days): 1) Absolute number of neutrophils (ANC) ≥ 1.5 x 10^9/L; 2) Platelets ≥ 100 x 10^9/L; 3) Hemoglobin ≥ 90 g/L ; 4) White blood cell (WBC) ≥ 3.0×10^9/L and ≤15×10^9/L; 5) Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); 6) AST (SGOT) and ALT (SGPT) ≤ 2.5 x ULN; 7) serum creatinine (Cr) ≤1.5×ULN, and creatinine clearance (CrCL) ≥50 mL/min (Cockcroft-Gault equation); 8) Prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤1.5 ULN with international normalized ratio (INR) ≤1.5 ULN (not receiving anticoagulation); 9) Serum albumin ≥ 2.5g/dL.
- Left ventricular ejection fraction (LVEF) ≥ 50%.
- 12-lead ECG: QT interval corrected by Fridericia method (QTcF) < 470 msec.
- Urine test: urinary protein < 2+; If urinary protein ≥ 2+, 24-hour urinary protein quantification must show protein ≤1g.
- Subject is willing and able to comply with the protocol (including contraceptive measures) for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
- With good compliance with the planned treatment, are able to understand the follow-up procedures of this study and sigh the informed consent form.
Who cannot join
- Patients with any of the following were not enrolled in the study:
- Cancer-related history and treatment history: 1) Bilateral breast cancer; 2) Previous history of ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS); 3) Previous history of invasive or metastatic breast cancer; 4) Any malignant tumor was diagnosed within 3 years before signing the informed consent, excluding cured cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma; 5) Received systemic chemotherapy, systemic targeted therapy and local radiotherapy within 3 years before signing the informed consent; 6) Previously treated with VEGFR small molecule tyrosine kinase inhibitors (such as famitinib, sorafenib, sunitinib, regorafenib, etc.) (except bevacizumab); 7) Prior treatment with PARP inhibitors for any disease;
- Stage IV breast cancer according to the AJCC staging system, 8th edition.
- Inflammatory breast cancer or breast rupture.
- There are clinical symptoms or diseases of the heart that are not well controlled
- Hypertension that is not well controlled by antihypertensive medication: systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 90 mmHg has a history of hypertensive crisis or hypertensive encephalopathy.
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- NCI-CTCAE v5.0 grade ≥2 bleeding events occurred within 4 weeks before the first medication, including but not limited to hemoptysis (single episode of hemoptysis volume ≥ 2mL), vaginal bleeding, gastrointestinal bleeding, etc.
- Excessive arterial/venous thrombosis events occurred within 6 months before the first medication, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc. Patients with lower extremity intermuscular venous thrombosis who were evaluated as not requiring anticoagulant therapy, and those whose mural thrombus caused by catheterization had disappeared and did not require drug therapy were considered for enrollment.
- Inability to swallow tablets normally or abnormal gastrointestinal function, which may affect drug absorption as judged by the researcher;
- Receipt of a strong inhibitor of CYP3A4, CYP2D6, P-gp, or BCRP from the date of first dose <5 times of drug half-lives or 14 days; The interval between receiving treatment with the above enzyme strong inducers and the first dose < 28 days.
- Evidence of any disease as judged by the investigator (e.g., severe or uncontrolled systemic disease, including severe systemic infection, uncontrolled hypertension, renal transplantation and active bleeding disease, coagulation disorders, platelet dysfunction, severe chronic gastrointestinal disease, or patients with other serious medical conditions);
- Have undergone major surgery other than invasive diagnostic procedures, peripherally inserted central catheter (PICC) procedures, or pathological biopsy within 28 days prior to the first dose, or are expected to undergo major surgery during the study period;
- Unhealed wounds, ulcers, or fractures;
- Active hepatitis B (defined as hepatitis B surface antigen [HBsAg] positive and HBV-DNA ≥500IU/ml);
- Hepatitis C infection (defined as a positive test for hepatitis C virus antibody [HCV-Ab] and an HCV-RNA test higher than the lower limit of the assay);
- Known history of human immunodeficiency virus (HIV) infection;
- Known history of psychotropic substance abuse, alcohol or drug abuse;
- Active psychiatric disorders (schizophrenia, major depressive disorder, bipolar disorder, etc.) and depression being treated with antidepressants were not exclusion criteria.
- Patients with known allergy or intolerance to the study drug or its excipents;
- Patients of reproductive age who are pregnant or lactating, and who refuse to use appropriate contraception during the course of the trial;
- Participated in other trial studies within 30 days before the first dose of the study drug, or not more than 5 half-lives since the last dose of the study drug;
- Patients judged by the investigator to be ineligible for the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Breast cancer institute of Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, 200032
Zhi-Ming Shao, MD, 86-21-641755901105, zhimingshao@yahoo.com
Junjie Li, MD, 86-21-64175590, lijunjie_ronaldo@hotmail.com
About this study
Official title: Neoadjuvant Treatment of gBRCA-Mutated HER2-Negative Breast Cancer With HRS-1167 and Famitinib/ HRS-1167, Famitinib and Camrelizumab: A Prospective, Open-label, Multicenter, Phase II Trial
This study is a prospective, open-label, multi-center, phase II clinical trial designed for HER2-negative breast cancer with pathogenic mutations in the germline gene (gBRCA1/2) that were indicated for neoadjuvant chemotherapy. The characteristics of this study are a precision treatment scheme without chemotherapy, the scheme of HRS-1167 combined with famitinib neoadjuvant therapy for patients with gBRCA mutations is explored, and the efficacy of combined immunotherapy is further explored according to the efficacy of the combination of the two drugs.
Read the detailed description
This study is a prospective, open-label, multi-center, phase II clinical trial designed for HER2-negative breast cancer with pathogenic mutations in the germline gene (gBRCA1/2) that were indicated for neoadjuvant chemotherapy. The characteristics of this study are a precision treatment scheme without chemotherapy, the scheme of HRS-1167 combined with famitinib neoadjuvant therapy for patients with gBRCA mutations is explored, and the efficacy of combined immunotherapy is further explored according to the efficacy of the combination of the two drugs. The study consists of a safety run-in period to explore the safety of HRS-1167 combined with famitinib, which is used to provide a recommended dose for the combination of HRS-1167 and famitinib. The latter phase II period is used to explore the efficacy of HRS-1167 plus famitinib /HRS-1167 plus famitinib plus camrelizumab as neoadjuvant therapy for gBRCA-mutated HER2-negative breast cancer. The primary endpoints in safety run-in period: the incidence of dose-limiting toxicity (DLT), the incidence and severity of adverse events (AE) and serious adverse events (SAE) ; in phase 2: the rate of pathological complete response (pCR) after surgery for each cohort as assessed by the investigator. Secondary endpoints included residual cancer burden (RCB) score, 3-year event-free survival (EFS), objective response rate (ORR), complete cell cycle arrest (CCCA) rate for HR+/HER2 - breast cancer, safety, and translational exploration study.
- Being tested
- HRS-1167, Famitinib, Camrelizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-1167Drug
a highly selective PARP1 inhibitor
FamitinibDrug
a tyrosine kinase inhibitor targeting VEGFR2, PDGFR, and c-kit
CamrelizumabDrug
a humanised anti-programmed death-1 (anti PD-1) antibody
| Study group | Role | What they receive |
|---|---|---|
| Safety run-in | Experimental | HRS-1167 + famitinib Receives: Drug: HRS-1167; Drug: Famitinib |
| Phase 2: Cohort A (HR+/HER2-, gBRCAm) | Experimental | HRS-1167 + famitinib, RP2D Receives: Drug: HRS-1167; Drug: Famitinib |
| Phase 2: Cohort B (HR-/HER2-, gBRCAm) | Experimental | HRS-1167 + famitinib, RP2D Receives: Drug: HRS-1167; Drug: Famitinib |
| Phase 2: Cohort C (HR+/HER2-, gBRCAm expansion cohort) | Experimental | HRS-1167 + famitinib, (RP2D) + camrelizumab Receives: Drug: HRS-1167; Drug: Famitinib; Drug: Camrelizumab |
| Phase 2: Cohort D (HR-/HER2-, gBRCAm expansion cohort) | Experimental | HRS-1167 + famitinib, (RP2D) + camrelizumab Receives: Drug: HRS-1167; Drug: Famitinib; Drug: Camrelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety run-in: Incidence rate of dose-limiting toxicities (DLTs)
Incidence rate of DLT will be evaluated in participants in the Safety Run-In, who will be followed for protocol-defined DLT events up to 28±3 days after the first dose of HRS-1167 and famitinib.
Measured: 28±3 days
Safety run-in: adverse events (AEs)
Incidence rate of AEs of any cause will be evaluated in participants in the Safety Run-In according to CTCAE v5.0.
Measured: 28±3 days
Safety run-in: Serious adverse events (SAEs)
Incidence rate of SAEs of any cause will be evaluated in participants in the Safety Run-In according to CTCAE v5.0.
Measured: 28±3 days
Phase 2: Total Pathologic complete response (tpCR: ypT0/Tis ypN0) rate
Defined as no residual invasive cancer cells are found in the pathological examination of breast and axillary lymph node; if only residual in situ cancer cells are present in the surgical specimens, it can also be considered as achieving a pathological complete response.
Measured: Immediately after the surgery
Secondary outcomes (8)
Phase 2: Residual Cancer Burden (RCB)
RCB will be estimated from routine pathological sections of the primary breast tumor site and the regional lymph nodes after the completion of neoadjuvant therapy. The pathological variables include bidimensional diameters of the primary tumor bed, the proportion of primary tumor area containing invasive carcinoma, the number of positive lymph nodes, and the diameter of the largest nodal metastasis
Measured: Immediately after the surgery
Phase 2: Event-free survival (EFS)
Defined as the time from the date of the first study dose to any of the following events: progression of disease that precludes surgery, local or distant recurrence, second primary malignancy (breast or other cancers) or death due to any cause.
Measured: Approximately 3 years
Phase 2: Objective response rate (ORR)
Defined as the proportion of patients with complete response (CR) and partial response (PR) by magnetic resonance imaging (MRI) according to RECIST v1.1.
Measured: Immediately after the surgery
Phase 2: Rate of complete cell cycle arrest (CCCA) in HR+/HER2- breast cancer
Rate of CCCA determined by IHC Ki67 ( Ki67 ≤ 2.7%) between pre- and post-treatment.
Measured: After 4 weeks of therapy
Phase 2: Adverse events (AEs)
Incidence rate of AEs of any cause will be evaluated in participants enrolled in the phase 2 period according to CTCAE v5.0.
Measured: Up to 6 months
Phase 2: Serious adverse events (SAEs)
Incidence rate of SAEs of any cause will be evaluated in participants enrolled in the phase 2 period according to CTCAE v5.0.
Measured: Up to 6 months
Biomarker analysis1
Gene mutations in the paired tumor and peripheral blood will be tested and analysed to predict therapy response.
Measured: At baseline, at the end of first 2 cycles (each cycle is 28 days) and immediately after the surgery
Biomarker analysis 2
Gene expression signatures in the paired tumor and peripheral blood will be tested and analysed to predict therapy response.
Measured: At baseline, at the end of first 2 cycles (each cycle is 28 days) and immediately after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start30 Sep 2024
- Primary completionJun 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BRCA-Mutated Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhimin Shao, Fudan University
- Investigators
- Zhi-Ming Shao, MD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06516289
- Sponsor's protocol ID
- SCHBCC-N074
- Status last verified
- Dec 2024
- First submitted
- 1 Jul 2024
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Treatment of gBRCA-Mutated HER2-Negative Breast Cancer With HRS-1167 and Famitinib/ HRS-1167, Famitinib and Camrelizumab: A Prospective, Open-label, Multicenter, Phase II Trial
- ClinicalTrials.gov ID
- NCT06516289
- Acronym / sponsor ID
- SCHBCC-N074
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 23 Jul 2024 (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 study is a prospective, open-label, multi-center, phase II clinical trial designed for HER2-negative breast cancer with pathogenic mutations in the germline gene (gBRCA1/2) that were indicated for neoadjuvant chemotherapy. The characteristics of this study are a precision treatment scheme without chemotherapy, the scheme of HRS-1167 combined with famitinib neoadjuvant therapy for patients with gBRCA mutations is explored, and the efficacy of combined immunotherapy is further explored according to the efficacy of the combination of the two drugs.
Detailed description
This study is a prospective, open-label, multi-center, phase II clinical trial designed for HER2-negative breast cancer with pathogenic mutations in the germline gene (gBRCA1/2) that were indicated for neoadjuvant chemotherapy. The characteristics of this study are a precision treatment scheme without chemotherapy, the scheme of HRS-1167 combined with famitinib neoadjuvant therapy for patients with gBRCA mutations is explored, and the efficacy of combined immunotherapy is further explored according to the efficacy of the combination of the two drugs. The study consists of a safety run-in period to explore the safety of HRS-1167 combined with famitinib, which is used to provide a recommended dose for the combination of HRS-1167 and famitinib. The latter phase II period is used to explore the efficacy of HRS-1167 plus famitinib /HRS-1167 plus famitinib plus camrelizumab as neoadjuvant therapy for gBRCA-mutated HER2-negative breast cancer. The primary endpoints in safety run-in period: the incidence of dose-limiting toxicity (DLT), the incidence and severity of adverse events (AE) and serious adverse events (SAE) ; in phase 2: the rate of pathological complete response (pCR) after surgery for each cohort as assessed by the investigator. Secondary endpoints included residual cancer burden (RCB) score, 3-year event-free survival (EFS), objective response rate (ORR), complete cell cycle arrest (CCCA) rate for HR+/HER2 - breast cancer, safety, and translational exploration study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Safety run-in | Experimental | Drug: HRS-1167, Drug: FamitinibHRS-1167 + famitinib |
| Phase 2: Cohort A (HR+/HER2-, gBRCAm) | Experimental | Drug: HRS-1167, Drug: FamitinibHRS-1167 + famitinib, RP2D |
| Phase 2: Cohort B (HR-/HER2-, gBRCAm) | Experimental | Drug: HRS-1167, Drug: FamitinibHRS-1167 + famitinib, RP2D |
| Phase 2: Cohort C (HR+/HER2-, gBRCAm expansion cohort) | Experimental | Drug: HRS-1167, Drug: Famitinib, Drug: CamrelizumabHRS-1167 + famitinib, (RP2D) + camrelizumab |
| Phase 2: Cohort D (HR-/HER2-, gBRCAm expansion cohort) | Experimental | Drug: HRS-1167, Drug: Famitinib, Drug: CamrelizumabHRS-1167 + famitinib, (RP2D) + camrelizumab |
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)
- Age 18 to 70 years old, female.
- Patients with histologically confirmed unilateral primary invasive breast cancer who meet the criteria of cT0-4, N1-3, M0 or cT≥3, N0, M0 (inflammatory breast cancer not included).
- Patients with HER-2 negative disease. HER2-negative disease was defined as follows: disease whose HER-2 is 1+ or negative by immunohistochemical (IHC), or fluorescence in situ hybridization (FISH) is negative if IHC is 2+.
- Patients with pathogenic germline BRCA 1/2 mutation.
- According to the RECIST 1.1 criteria, there is at least one measurable objective lesion.
Key exclusion criteria (22 listed)
- Cancer-related history and treatment history: 1) Bilateral breast cancer; 2) Previous history of ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS); 3) Previous history of invasive or metastatic breast cancer; 4) Any malignant tumor was diagnosed within 3 years before signing the informed consent, excluding cured cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma; 5) Received systemic chemotherapy, systemic targeted therapy and local radiotherapy within 3 years before signing the informed consent; 6) Previously treated with VEGFR small molecule tyrosine kinase inhibitors (such as famitinib, sorafenib, sunitinib, regorafenib, etc.) (except bevacizumab); 7) Prior treatment with PARP inhibitors for any disease;
- Stage IV breast cancer according to the AJCC staging system, 8th edition.
- Inflammatory breast cancer or breast rupture.
- There are clinical symptoms or diseases of the heart that are not well controlled
- Hypertension that is not well controlled by antihypertensive medication: systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 90 mmHg has a history of hypertensive crisis or hypertensive encephalopathy.
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 |
|---|---|---|
| HRS-1167a highly selective PARP1 inhibitor | Drug | Phase 2: Cohort A (HR+/HER2-, gBRCAm), Phase 2: Cohort B (HR-/HER2-, gBRCAm), Phase 2: Cohort C (HR+/HER2-, gBRCAm expansion cohort), Phase 2: Cohort D (HR-/HER2-, gBRCAm expansion cohort), Safety run-in |
| Famitiniba tyrosine kinase inhibitor targeting VEGFR2, PDGFR, and c-kit | Drug | Phase 2: Cohort A (HR+/HER2-, gBRCAm), Phase 2: Cohort B (HR-/HER2-, gBRCAm), Phase 2: Cohort C (HR+/HER2-, gBRCAm expansion cohort), Phase 2: Cohort D (HR-/HER2-, gBRCAm expansion cohort), Safety run-in |
| Camrelizumaba humanised anti-programmed death-1 (anti PD-1) antibody | Drug | Phase 2: Cohort C (HR+/HER2-, gBRCAm expansion cohort), Phase 2: Cohort D (HR-/HER2-, gBRCAm expansion cohort) |
Primary outcome
Safety run-in: Incidence rate of dose-limiting toxicities (DLTs)
Time frame: 28±3 days
Incidence rate of DLT will be evaluated in participants in the Safety Run-In, who will be followed for protocol-defined DLT events up to 28±3 days after the first dose of HRS-1167 and famitinib.
Safety run-in: adverse events (AEs)
Time frame: 28±3 days
Incidence rate of AEs of any cause will be evaluated in participants in the Safety Run-In according to CTCAE v5.0.
Safety run-in: Serious adverse events (SAEs)
Time frame: 28±3 days
Incidence rate of SAEs of any cause will be evaluated in participants in the Safety Run-In according to CTCAE v5.0.
Phase 2: Total Pathologic complete response (tpCR: ypT0/Tis ypN0) rate
Time frame: Immediately after the surgery
Defined as no residual invasive cancer cells are found in the pathological examination of breast and axillary lymph node; if only residual in situ cancer cells are present in the surgical specimens, it can also be considered as achieving a pathological complete response.
8 secondary outcomes
Phase 2: Residual Cancer Burden (RCB)
Time frame: Immediately after the surgery
Phase 2: Event-free survival (EFS)
Time frame: Approximately 3 years
Phase 2: Objective response rate (ORR)
Time frame: Immediately after the surgery
Phase 2: Rate of complete cell cycle arrest (CCCA) in HR+/HER2- breast cancer
Time frame: After 4 weeks of therapy
Phase 2: Adverse events (AEs)
Time frame: Up to 6 months
Phase 2: Serious adverse events (SAEs)
Time frame: Up to 6 months
Biomarker analysis1
Time frame: At baseline, at the end of first 2 cycles (each cycle is 28 days) and immediately after the surgery
Biomarker analysis 2
Time frame: At baseline, at the end of first 2 cycles (each cycle is 28 days) and immediately after the surgery
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 12 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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.
Zhi-Ming Shao, MD principal investigator
Fudan University
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 HRS-1167, Famitinib and Camrelizumab in people with BRCA-Mutated Breast Carcinoma and HER2-negative Breast Cancer, run by Fudan 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 22 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: looking for participants now, as of the sponsor's last update on 12 Dec 2024. 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?
Contact Zhi-Ming Shao, MD (86-21-641755901105, zhimingshao@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety run-in: Incidence rate of dose-limiting toxicities (DLTs) (time frame: 28±3 days). The study lists 4 primary outcomes in all. 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 12 Dec 2024.