Treatment in HER2-negative Metastatic Breast Cancer Patients With Germline BRCA MutationPhase 3NCT04296370
A Study of Fluzoparib±Apatinib Versus Chemotherapy Treatment of Physician's Choice in HER2-negative Metastatic Breast Cancer Patients With Germline BRCA Mutation
A Phase 3 study testing Fluzoparib; Apatinib, Fluzoparib and Physician's choice chemotherapy in people with Treatment in HER2-negative Metastatic Breast Cancer Patients With Germline BRCA Mutation, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
This is a multicenter, randomized, open-label, 3-arm Phase 3 study to evaluate the efficacy and safety of Fluzoparib alone or with Apatinib versus Physicians Choice Chemotherapy, as treatment, in patients with a Germline BRCA Mutation and HER2-negative Metastatic Breast Cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Treatment in HER2-negative Metastatic Breast Cancer Patients With Germline BRCA Mutation
- What is being tested?
- Fluzoparib; Apatinib, Fluzoparib and Physician's choice chemotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 474 participants
- Where
- 1 siteChina
- Study dates
- 13 Jul 2020to 30 Jun 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- （Saftey Lead-in + phase 3）Germline mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious
- （Saftey Lead-in + phase 3）human epidermal growth factor receptor type 2 (HER2)-negative metastatic breast cancer
- （Saftey Lead-in + phase 3）had received ≤2 lines of chemotherapy for mBC
- （Saftey Lead-in + phase 3）Prior therapy with an anthracycline and a taxane in either an adjuvant or metastatic setting.
- ER/PR breast cancer positive patients must have received and progressed on at least one endocrine therapy (adjuvant or metastatic), or have disease that the treating physician believes to be inappropriate for endocrine therapy.
- ECOG performance status 0-1.
- Adequate bone marrow, kidney and liver function.
Who cannot join
- Prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor or Apatinib
- Prior malignancy unless curatively treated and disease-free for > 5 years prior to study entry. Prior adequately treated non-melanoma skin cancer, in situ cancer of the cervix, DCIS or stage I grade 1 endometrial cancer allowed
- Radiation or anti-hormonal therapy or other targeted anticancer therapy within 14 days before randomization
- Known to be human immunodeficiency virus positive
- Known active hepatitis C virus, or known active hepatitis B virus
- Untreated and/or uncontrolled brain metastases
- Pregnant or breast-feeding women
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jiangsu HengRui Medicine Co., Ltd.
Shanghai
Quanren Wang, +86 18036618570, wangquanren@hrglobe.cn
Xiaodi Wang, +86 13811442099, wangxiaodi@hrglobe.cn
About this study
Official title: A Phase III, Open Label, Randomised, Controlled, Multi-centre Study to Assess the Efficacy and Safety of Fluzoparib±Apatinib Versus Physicians Choice Chemotherapy in the Treatment of HER2-negative Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations
This is a multicenter, randomized, open-label, 3-arm Phase 3 study to evaluate the efficacy and safety of Fluzoparib alone or with Apatinib versus Physicians Choice Chemotherapy, as treatment, in patients with a Germline BRCA Mutation and HER2-negative Metastatic Breast Cancer. The study contains a Safety Lead-in Phase in which the safety and tolerability of Fluzoparib+Apatinib will be assessed prior to the Phase 3 portion of the study.
- Being tested
- Fluzoparib; Apatinib, Fluzoparib, Physician's choice chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluzoparib; ApatinibDrug
Fluzoparib Orally twice daily; Apatinib Orally once daily
FluzoparibDrug
Fluzoparib Orally twice daily
Physician's choice chemotherapyDrug
Investigators will declare one of the following regimens:
Capecitabine Vinorelbine
| Study group | Role | What they receive |
|---|---|---|
| Safety Lead-in, Doublet Arm | Experimental | Fluzoparib+Apatinib Receives: Drug: Fluzoparib; Apatinib |
| Single Arm | Experimental | Fluzoparib Receives: Drug: Fluzoparib |
| Physician's choice chemotherapy | Active comparator | Capecitabine or Vinorelbine Receives: Drug: Physician's choice chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
(Safety Lead-in) dose limited toxicity (DLT)
dose limited toxicity (DLT) of Fluzoparib+Apatinib in the first cycle
Measured: up to 21 days
(Safety Lead-in) Recommended Phase II Dose (RP2D)
Recommended Phase II Dose (RP2D) of Fluzoparib+Apatinib
Measured: up to 21 days
(Phase 3) Progression free survival(PFS) in HER2-negative Metastatic Breast Cancer patients
Defined as progression free survival per RECIST 1.1 criteria according to BIRC criteria
Measured: Radiological scans performed at baseline then every ~6 weeks up to 30 weeks, then every ~ 9 weeks thereafter until objective radiological disease progression. Assessed up to a maximum of 30 months
Secondary outcomes (8)
AEs+SAEs
Adverse Events and Serious Adverse Events
Measured: from the first drug administration to within 30 days for the last treatment dose
PFS by investigator's assessment
Progression-Free-Survival
Measured: up to 30 months
OS
OS is the time interval from the start of treatment to death due to any reason or lost of follow-up
Measured: up to 30 months
Patient Reported Outcomes (PROs) assessed by EORTC QLQ C30 questionnaire
Comparison of the Quality of Life in study arms assessed by EORTC QLQ C30 questionnaire
Measured: up to 30 months
Time to progression on the next anticancer therapy (PFS2)
From date of start of next anticancer therapy to date of first documented progression of date of death from any cause, whichever comes first
Measured: up to 30 months
Objective Response Rate (ORR)
Number of responders Assessed by Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1) for target lesions assessed by CT or MRI
Measured: up to 30 months
Disease control rate (DCR)
Complete response + Partial response + Stable disease (CR+PR+SD) based on RECIST 1.1
Measured: up to 30 months
Duration of response (DoR)
Time from documentation of tumor response to disease progression assessed among patients who had an objective response
Measured: up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start13 Jul 2020
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Treatment in HER2-negative Metastatic Breast Cancer Patients With Germline BRCA MutationStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 474 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04296370
- Sponsor's protocol ID
- FZPL-Ⅲ-303
- Status last verified
- Mar 2020
- First submitted
- 3 Mar 2020
- Last updated
- 10 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li H, Liu J, Ouyang Q, Wang S, Liu Y, Teng Y, Wang X, Cheng J, Tong Z, Sun T, Yan M, Zhou X, Li F, Nie J, Shao ZM, Ye C, Wang Y, Wu X, Li Z, Wu Y, Xiong H, Li H, Gan L, Niu Z, Zhang J, Zhang Q, Pan Y, Wu X, Zhang Y, Xie W, Xiao Y, Gao J, Zhao H, Yin Y, Qian Z, Sun S, Zhang H, Wang K, Lu J, Li Y, Wang X, Yang X, Wang Y, Wang Q, Song E. Fuzuloparib with or without apatinib in patients with HER2-negative metastatic breast cancer with germline BRCA1/2 mutations (FABULOUS): interim analysis of a multicentre, three-arm, open-label, randomised, phase 3 trial. Lancet Oncol. 2025 Dec;26(12):1563-1574. doi: 10.1016/S1470-2045(25)00523-6.
PubMed 41308673
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Open Label, Randomised, Controlled, Multi-centre Study to Assess the Efficacy and Safety of Fluzoparib±Apatinib Versus Physicians Choice Chemotherapy in the Treatment of HER2-negative Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations
- ClinicalTrials.gov ID
- NCT04296370
- Acronym / sponsor ID
- FZPL-Ⅲ-303
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 474 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Jul 2020 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 5 Mar 2020 (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 is a multicenter, randomized, open-label, 3-arm Phase 3 study to evaluate the efficacy and safety of Fluzoparib alone or with Apatinib versus Physicians Choice Chemotherapy, as treatment, in patients with a Germline BRCA Mutation and HER2-negative Metastatic Breast Cancer. The study contains a Safety Lead-in Phase in which the safety and tolerability of Fluzoparib+Apatinib will be assessed prior to the Phase 3 portion of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Safety Lead-in, Doublet Arm | Experimental | Drug: Fluzoparib; ApatinibFluzoparib+Apatinib |
| Single Arm | Experimental | Drug: FluzoparibFluzoparib |
| Physician's choice chemotherapy | Active comparator | Drug: Physician's choice chemotherapyCapecitabine or Vinorelbine |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- （Saftey Lead-in + phase 3）Germline mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious
- （Saftey Lead-in + phase 3）human epidermal growth factor receptor type 2 (HER2)-negative metastatic breast cancer
- （Saftey Lead-in + phase 3）had received ≤2 lines of chemotherapy for mBC
- （Saftey Lead-in + phase 3）Prior therapy with an anthracycline and a taxane in either an adjuvant or metastatic setting.
- ER/PR breast cancer positive patients must have received and progressed on at least one endocrine therapy (adjuvant or metastatic), or have disease that the treating physician believes to be inappropriate for endocrine therapy.
Key exclusion criteria (7 listed)
- Prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor or Apatinib
- Prior malignancy unless curatively treated and disease-free for > 5 years prior to study entry. Prior adequately treated non-melanoma skin cancer, in situ cancer of the cervix, DCIS or stage I grade 1 endometrial cancer allowed
- Radiation or anti-hormonal therapy or other targeted anticancer therapy within 14 days before randomization
- Known to be human immunodeficiency virus positive
- Known active hepatitis C virus, or known active hepatitis B virus
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 |
|---|---|---|
| Fluzoparib; ApatinibFluzoparib Orally twice daily; Apatinib Orally once daily | Drug | Safety Lead-in, Doublet Arm |
| FluzoparibFluzoparib Orally twice daily | Drug | Single Arm |
| Physician's choice chemotherapyInvestigators will declare one of the following regimens: Capecitabine Vinorelbine | Drug | Physician's choice chemotherapy |
Primary outcome
(Safety Lead-in) dose limited toxicity (DLT)
Time frame: up to 21 days
dose limited toxicity (DLT) of Fluzoparib+Apatinib in the first cycle
(Safety Lead-in) Recommended Phase II Dose (RP2D)
Time frame: up to 21 days
Recommended Phase II Dose (RP2D) of Fluzoparib+Apatinib
(Phase 3) Progression free survival(PFS) in HER2-negative Metastatic Breast Cancer patients
Time frame: Radiological scans performed at baseline then every ~6 weeks up to 30 weeks, then every ~ 9 weeks thereafter until objective radiological disease progression. Assessed up to a maximum of 30 months
Defined as progression free survival per RECIST 1.1 criteria according to BIRC criteria
8 secondary outcomes
AEs+SAEs
Time frame: from the first drug administration to within 30 days for the last treatment dose
PFS by investigator's assessment
Time frame: up to 30 months
OS
Time frame: up to 30 months
Patient Reported Outcomes (PROs) assessed by EORTC QLQ C30 questionnaire
Time frame: up to 30 months
Time to progression on the next anticancer therapy (PFS2)
Time frame: up to 30 months
Objective Response Rate (ORR)
Time frame: up to 30 months
Disease control rate (DCR)
Time frame: up to 30 months
Duration of response (DoR)
Time frame: up to 30 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2020.
- Derived from this study: PubMed 41308673Li H, Liu J, Ouyang Q, Wang S, Liu Y, Teng Y, Wang X, Cheng J, Tong Z, Sun T, Yan M, Zhou X, Li F, Nie J, Shao ZM, Ye C, Wang Y, Wu X, Li Z, Wu Y, Xiong H, Li H, Gan L, Niu Z, Zhang J, Zhang Q, Pan Y, Wu X, Zhang Y, Xie W, Xiao Y, Gao J, Zhao H, Yin Y, Qian Z, Sun S, Zhang H, Wang K, Lu J, Li Y, Wang X, Yang X, Wang Y, Wang Q, Song E. Fuzuloparib with or without apatinib in patients with HER2-negative metastatic breast cancer with germline BRCA1/2 mutations (FABULOUS): interim analysis of a multicentre, three-arm, open-label, randomised, phase 3 trial. Lancet Oncol. 2025 Dec;26(12):1563-1574. doi: 10.1016/S1470-2045(25)00523-6.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fluzoparib; Apatinib, Fluzoparib and Physician's choice chemotherapy in people with Treatment in HER2-negative Metastatic Breast Cancer Patients With Germline BRCA Mutation, run by Jiangsu HengRui Medicine Co., Ltd. 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 7 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 10 Aug 2020. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(Safety Lead-in) dose limited toxicity (DLT) (time frame: up to 21 days). The study lists 3 primary outcomes in all. 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 NCT04296370, which also lists 1 linked publication.
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 10 Aug 2020.