Breast CancerPhase 3NCT06954961
A Study to Evaluate D-0502 in Subjects With ER+ Her2- Locally Advanced or Metastatic Breast Cancer
A Phase 3 study testing D-0502 and Fulvestrant in people with Breast Cancer, run by InventisBio Co., Ltd at 2 sites in China.
Trial summary
This is a randomized, parallel-controlled, open-label, multicenter clinical study to assess the efficacy and safety of D-0502 in the treatment of subjects with ER-positive, HER2-negative locally advanced or metastatic breast cancer with fulvestrant injection as a control drug. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- D-0502 and Fulvestrant
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 640 participants
- Where
- 2 sitesChina
- Study dates
- 15 Sep 2022to 31 Dec 2028
- Phase
- Phase 3
- 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
- Subjects pathologically confirmed with ER-positive, HER2-negative breast cancer;
- Subjects with locally advanced (unresectable) or metastatic breast cancer who have disease recurrence during or after adjuvant endocrine therapy, or whose disease has progressed after 1-2 lines of systemic endocrine therapy;
- Presence of at least 1 measurable lesion that can be measured by CT or MRI based on RECIST V1.1 criteria; in the absence of measurable lesions, subjects with evaluable bone lesions [osteolytic or mixed (osteolytic + osteogenic) bone lesions] are also acceptable. Lesions that have been previously treated with radiotherapy or other local therapy can be regarded as measurable lesions only if there is disease progression as confirmed by imaging examination;
- Expected survival time ≥ 12 weeks;
Who cannot join
- Subjects with unstable or symptomatic or progressive central nervous system (CNS) metastases. Subjects with a history of brain metastases who are clinically stable and have no CNS disease progression confirmed by brain MRI or CT (if MRI is not appropriate) can be enrolled (MRI or CT examination must be conducted at least 4 weeks after the last brain radiotherapy);
- Subjects with locally advanced or metastatic breast cancer who have previously received more than 2 prior systemic chemotherapy;
- Subjects are unsuitable for endocrine therapy judged by the investigator, including uncontrolled pleural effusion, ascites or pericardial effusion;
- Subjects with concomitant medical conditions that the investigator believes may increase the risk of toxicity, such as serious cardiovascular, respiratory or neurological diseases;
- Prior treatment with a selective estrogen receptor degrader (SERD)/selective estrogen receptor covalent antagonist (SERCA), such as fulvestrant, GDC-9545, AZD9833, SAR-439859, Zn -c5, LX-039, HS234, etc.;
- Pregnant or lactating females;
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Cancer Hospital Chinese Academy of Medical Science
Beijing, Beijing Municipality, 100021
Binghe Xu, 8613501028690, xubinghe@medmail.com.cn
- Recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
Qingyuan Zhang, 13313612989, sy86298276@163.com
About this study
Official title: A Randomized, Parallel-controlled, Open-label, Multicenter Phase III Clinical Study to Compare the Efficacy and Safety of D-0502 With Fulvestrant in Patients With Previously Treated ER-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer
This is a randomized, parallel-controlled, open-label, multicenter clinical study to assess the efficacy and safety of D-0502 in the treatment of subjects with ER-positive, HER2-negative locally advanced or metastatic breast cancer with fulvestrant injection as a control drug.
- Conditions
- Breast Cancer
- Being tested
- D-0502, Fulvestrant
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-0502Drug
- Dosage form: Tablet
- Administration route: Oral, once a day
FulvestrantDrug
- Dosage form: Injection
- Administration route: Intramuscular injection, once a month, and another dose administered two weeks after the first dose
| Study group | Role | What they receive |
|---|---|---|
| D-0502 | Experimental | Not described Receives: Drug: D-0502 |
| Fulvestrant | Active comparator | Not described Receives: Drug: Fulvestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS) assessed by Independent Review Committee (IRC)
Measured: From enrollment to the end of treatment, up to 2 years
Secondary outcomes (8)
Progression free survival (PFS) -assessed by investigators
Measured: From enrollment to the end of treatment, up to 2 years
Objective response rate (ORR) -assessed by IRC and investigators
Measured: From enrollment to the end of treatment, up to 2 years
Clinical benefit rate (CBR) -assessed by IRC and investigators
Measured: From enrollment to the end of treatment, up to 2 years
Disease control rate (DCR)-assessed by IRC and investigators
Measured: From enrollment to the end of treatment, up to 2 years
Clearance (Cl) of D-0502
Measured: on Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 and Cycle 3 Day 1 (each cycle is 28 days)
Overall Survival (OS)
Measured: From end of treatment to end of study, about 2 years
Number of participants with adverse events/serious adverse events and abnormal laboratory test results
Measured: From enrollment to 30 days after last dose
Volume of distribution (Vd) of D-0502
Measured: on Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 and Cycle 3 Day 1 (each cycle is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study start15 Sep 2022
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 640 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InventisBio Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Binghe Xu, MD, Principal investigator, Cancer HospitalQingyuan Zhang, MD, Principal investigator, Harbin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06954961
- Sponsor's protocol ID
- D0502-303
- Status last verified
- Mar 2026
- First submitted
- 20 Dec 2024
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Parallel-controlled, Open-label, Multicenter Phase III Clinical Study to Compare the Efficacy and Safety of D-0502 With Fulvestrant in Patients With Previously Treated ER-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT06954961
- Acronym / sponsor ID
- D0502-303
- Conditions
- Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 640 participants (estimated)
- Lead sponsor
- InventisBio Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 2 May 2025 (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 randomized, parallel-controlled, open-label, multicenter clinical study to assess the efficacy and safety of D-0502 in the treatment of subjects with ER-positive, HER2-negative locally advanced or metastatic breast cancer with fulvestrant injection as a control drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| D-0502 | Experimental | Drug: D-0502 |
| Fulvestrant | Active comparator | Drug: Fulvestrant |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects pathologically confirmed with ER-positive, HER2-negative breast cancer;
- Subjects with locally advanced (unresectable) or metastatic breast cancer who have disease recurrence during or after adjuvant endocrine therapy, or whose disease has progressed after 1-2 lines of systemic endocrine therapy;
- Presence of at least 1 measurable lesion that can be measured by CT or MRI based on RECIST V1.1 criteria; in the absence of measurable lesions, subjects with evaluable bone lesions [osteolytic or mixed (osteolytic + osteogenic) bone lesions] are also acceptable. Lesions that have been previously treated with radiotherapy or other local therapy can be regarded as measurable lesions only if there is disease progression as confirmed by imaging examination;
- Expected survival time ≥ 12 weeks;
Key exclusion criteria (6 listed)
- Subjects with unstable or symptomatic or progressive central nervous system (CNS) metastases. Subjects with a history of brain metastases who are clinically stable and have no CNS disease progression confirmed by brain MRI or CT (if MRI is not appropriate) can be enrolled (MRI or CT examination must be conducted at least 4 weeks after the last brain radiotherapy);
- Subjects with locally advanced or metastatic breast cancer who have previously received more than 2 prior systemic chemotherapy;
- Subjects are unsuitable for endocrine therapy judged by the investigator, including uncontrolled pleural effusion, ascites or pericardial effusion;
- Subjects with concomitant medical conditions that the investigator believes may increase the risk of toxicity, such as serious cardiovascular, respiratory or neurological diseases;
- Prior treatment with a selective estrogen receptor degrader (SERD)/selective estrogen receptor covalent antagonist (SERCA), such as fulvestrant, GDC-9545, AZD9833, SAR-439859, Zn -c5, LX-039, HS234, etc.;
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 |
|---|---|---|
| D-0502* Dosage form: Tablet * Administration route: Oral, once a day | Drug | D-0502 |
| Fulvestrant* Dosage form: Injection * Administration route: Intramuscular injection, once a month, and another dose administered two weeks after the first dose | Drug | Fulvestrant |
Primary outcome
Progression free survival (PFS) assessed by Independent Review Committee (IRC)
Time frame: From enrollment to the end of treatment, up to 2 years
8 secondary outcomes
Progression free survival (PFS) -assessed by investigators
Time frame: From enrollment to the end of treatment, up to 2 years
Objective response rate (ORR) -assessed by IRC and investigators
Time frame: From enrollment to the end of treatment, up to 2 years
Clinical benefit rate (CBR) -assessed by IRC and investigators
Time frame: From enrollment to the end of treatment, up to 2 years
Disease control rate (DCR)-assessed by IRC and investigators
Time frame: From enrollment to the end of treatment, up to 2 years
Clearance (Cl) of D-0502
Time frame: on Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 and Cycle 3 Day 1 (each cycle is 28 days)
Overall Survival (OS)
Time frame: From end of treatment to end of study, about 2 years
Number of participants with adverse events/serious adverse events and abnormal laboratory test results
Time frame: From enrollment to 30 days after last dose
Volume of distribution (Vd) of D-0502
Time frame: on Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 and Cycle 3 Day 1 (each cycle is 28 days)
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 31 Mar 2026.
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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.
Binghe Xu, MD principal investigator
Cancer Hospital
Qingyuan Zhang, MD principal investigator
Harbin
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing D-0502 and Fulvestrant in people with Breast Cancer, run by InventisBio Co., Ltd at 2 sites 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 4 inclusion and 6 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 31 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 2 sites 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?
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 Yuting Li (8615821378026, yuting.li@inventisbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) assessed by Independent Review Committee (IRC) (time frame: From enrollment to the end of treatment, up to 2 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 31 Mar 2026; AzTrials last refreshed its copy on 30 Oct 2026.