Breast Cancer MetastaticPhase 2NCT05759546
PARP Inhibitor With CDK4/6 Inhibitor and Endocrine Therapy in HR+/ HER2-Advanced Breast Cancer
A Phase 2 study testing Fluzoparib, Dalpiciclib and Fulvestrant/AI in people with Breast Cancer Metastatic, run by Fudan University at 1 site in China.
Trial summary
This study is a prospective, open-label, phase II clinical study for patients with HR+/HER2- advanced breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer Metastatic
- What is being tested?
- Fluzoparib, Dalpiciclib and Fulvestrant/AI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2023to 1 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females ≥18 years and ≤ 75 years old;
- Histologically confirmed HR + / HER2- invasive breast cancer (specific definition: immunohistochemical detection of ER> 10% tumor cell positive is defined as ER positive, PR> 10% tumor cell positive is defined as PR positive, ER and / or PR Positive is defined as HR positive; HER2 0-1 + or HER2 is ++ but negative followed by FISH detection, no amplification, defined as HER2 negative);
- Subtype of similarity network fusion-3 (SNF-3) confirmed by the Department of Pathology and Key Laboratory of Breast Cancer of Fudan University Affiliated Cancer Hospital • Locally advanced breast cancer (incapable of radical local treatment) or recurrent metastatic breast cancer;
- Measurable disease according to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1); or unmeasurable lytic or mixed (osteolytic + osteoblastic) bone lesions in the absence of measurable lesions;
- Has adequate bone marrow function: absolute neutrophil count > 1.5x10ˆ9 /L; platelet count > 75x10ˆ9 /L, hemoglobin > 9g/dL;
- Patients had received no previous chemotherapy or targeted therapy for metastatic disease
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- Has adequate liver function and kidney function: serum creatinine
- ECOG score ≤ 2 and life expectancy ≥ 3 months;
- Participants voluntarily joined the study, has signed informed consent before any trial related activities are conducted, has good compliance and has agreed to follow-up.
Who cannot join
- Treatment with chemotherapy, radiotherapy, immunotherapy or surgery (outpatient clinic surgery excluded) for metastatic disease
- Symptomatic, untreated, or actively progressing CNS metastases(glucocorticoids or mannitol needed to control symptoms);
- Significant cardiovascular disease(including congestive heart failure, angina pectoris, myocardial infarction or ventricular arrhythmia in the last 6 months);
- is pregnant or breast feeding;
- Malignant tumors in the past five years (except cured skin basal cell carcinoma and cervical carcinoma in situ).
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
Lei Fan, MD, 86-21-641755901105, cmchen@medmail.com.cn
About this study
Official title: PARP Inhibitor in Combination With CDK4/6 Inhibitor and Endocrine Therapy as the First-line Therapy for HR+/ HER2-Advanced Breast Cancer
This study is a prospective, open-label, phase II clinical study for patients with HR+/HER2- advanced breast cancer.
Read the detailed description
Patients with SNF3 subtype of HR+/HER2- advanced breast cancer confirmed by the Department of Pathology and Key Laboratory of Breast Cancer of Fudan University Affiliated Cancer Hospital are planned to be enrolled. The main purpose is to evaluate efficacy of PARP inhibitor in SNF3 subtype of HR+/HER2- advanced breast cancer and prepare for subsequent randomized controlled phase III clinical studies with larger sample size.
- Conditions
- Breast Cancer Metastatic
- Being tested
- Fluzoparib, Dalpiciclib, Fulvestrant/AI
- Keywords
- first-line therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluzoparibDrug
Parp inhibitor
DalpiciclibDrug
CDK4/6 inhibitor
Fulvestrant/AIDrug
Endocrine therapy
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | In this cohort, a patient would receive Dalpiciclib(CDK4/6 inhibitor) combined with Fluzoparib(Parp inhibitor) and endocrine therapy. Receives: Drug: Fluzoparib; Drug: Dalpiciclib; Drug: Fulvestrant/AI |
| Cohort 2 | Active comparator | In this cohort, a patient would receive Dalpiciclib(CDK4/6 inhibitor) combined with endocrine therapy. Receives: Drug: Dalpiciclib; Drug: Fulvestrant/AI |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
time to progressive disease (according to RECIST1.1)
Measured: Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 5 years)
Secondary outcomes (3)
ORR
The proportion of participants whose best outcome is complete remission or partial remission (according to RECIST1.1)
Measured: Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 5 years)
CBR
the percentage of subjects with CR+PR+SD and last more than 24 weeks in all of the participants.
Measured: : Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 5 years)
OS
time to death due to any cause
Measured: Randomization to death from any cause, through the end of study (approximately 5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start1 Feb 2023
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer MetastaticStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Cancer Hospital & Institute, First Hospital of China Medical University, Sun Yat-sen University, First Affiliated Hospital Xi'an Jiaotong University, Liaoning Cancer Hospital & Institute, Chongqing University Cancer Hospital, Northern Jiangsu People's Hospital, Fujian Medical University Union Hospital, Ningbo Medical Center Lihuili Hospital, Shanghai First Maternity and Infant Hospital, Shanghai 6th People's Hospital, Affiliated Hospital of Nantong University
- Responsible party
- Principal investigator, Zhimin Shao, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05759546
- Sponsor's protocol ID
- BCTOP-L-M03
- Status last verified
- Feb 2023
- First submitted
- 26 Feb 2023
- Last updated
- 6 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PARP Inhibitor in Combination With CDK4/6 Inhibitor and Endocrine Therapy as the First-line Therapy for HR+/ HER2-Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT05759546
- Acronym / sponsor ID
- BCTOP-L-M03
- Conditions
- Breast Cancer Metastatic
- Keywords
- first-line therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Peking University Cancer Hospital & Institute, First Hospital of China Medical University, Sun Yat-sen University, First Affiliated Hospital Xi'an Jiaotong University, Liaoning Cancer Hospital & Institute, Chongqing University Cancer Hospital, Northern Jiangsu People's Hospital, Fujian Medical University Union Hospital, Ningbo Medical Center Lihuili Hospital, Shanghai First Maternity and Infant Hospital, Shanghai 6th People's Hospital, Affiliated Hospital of Nantong University
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 8 Mar 2023 (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, phase II clinical study for patients with HR+/HER2- advanced breast cancer.
Detailed description
Patients with SNF3 subtype of HR+/HER2- advanced breast cancer confirmed by the Department of Pathology and Key Laboratory of Breast Cancer of Fudan University Affiliated Cancer Hospital are planned to be enrolled. The main purpose is to evaluate efficacy of PARP inhibitor in SNF3 subtype of HR+/HER2- advanced breast cancer and prepare for subsequent randomized controlled phase III clinical studies with larger sample size.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Fluzoparib, Drug: Dalpiciclib, Drug: Fulvestrant/AIIn this cohort, a patient would receive Dalpiciclib(CDK4/6 inhibitor) combined with Fluzoparib(Parp inhibitor) and endocrine therapy. |
| Cohort 2 | Active comparator | Drug: Dalpiciclib, Drug: Fulvestrant/AIIn this cohort, a patient would receive Dalpiciclib(CDK4/6 inhibitor) combined with endocrine therapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Females ≥18 years and ≤ 75 years old;
- Histologically confirmed HR + / HER2- invasive breast cancer (specific definition: immunohistochemical detection of ER> 10% tumor cell positive is defined as ER positive, PR> 10% tumor cell positive is defined as PR positive, ER and / or PR Positive is defined as HR positive; HER2 0-1 + or HER2 is ++ but negative followed by FISH detection, no amplification, defined as HER2 negative);
- Subtype of similarity network fusion-3 (SNF-3) confirmed by the Department of Pathology and Key Laboratory of Breast Cancer of Fudan University Affiliated Cancer Hospital • Locally advanced breast cancer (incapable of radical local treatment) or recurrent metastatic breast cancer;
- Measurable disease according to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1); or unmeasurable lytic or mixed (osteolytic + osteoblastic) bone lesions in the absence of measurable lesions;
- Has adequate bone marrow function: absolute neutrophil count > 1.5x10ˆ9 /L; platelet count > 75x10ˆ9 /L, hemoglobin > 9g/dL;
Key exclusion criteria (5 listed)
- Treatment with chemotherapy, radiotherapy, immunotherapy or surgery (outpatient clinic surgery excluded) for metastatic disease
- Symptomatic, untreated, or actively progressing CNS metastases(glucocorticoids or mannitol needed to control symptoms);
- Significant cardiovascular disease(including congestive heart failure, angina pectoris, myocardial infarction or ventricular arrhythmia in the last 6 months);
- is pregnant or breast feeding;
- Malignant tumors in the past five years (except cured skin basal cell carcinoma and cervical carcinoma in situ).
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 |
|---|---|---|
| FluzoparibParp inhibitor | Drug | Cohort 1 |
| DalpiciclibCDK4/6 inhibitor | Drug | Cohort 1, Cohort 2 |
| Fulvestrant/AIEndocrine therapy | Drug | Cohort 1, Cohort 2 |
Primary outcome
PFS
Time frame: Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 5 years)
time to progressive disease (according to RECIST1.1)
3 secondary outcomes
ORR
Time frame: Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 5 years)
CBR
Time frame: : Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 5 years)
OS
Time frame: Randomization to death from any cause, through the end of study (approximately 5 years)
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 6 Feb 2024.
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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.
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 Fluzoparib, Dalpiciclib and Fulvestrant/AI in people with Breast Cancer Metastatic, 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 9 inclusion and 5 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 6 Feb 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 Zhimin Shao (86-021-64175590 ext. 8888, zhimingshao@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 5 years)). 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 6 Feb 2024.