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

New breast cancer drug D-0502 tested against standard treatment

NCT: NCT06954961 · Status: RECRUITING · Phase: Phase 3 · Sponsor: InventisBio Co., Ltd · Started: 2022-09-15 · Est. Completion: 2028-12-31

Plain English Summary

A Study to Evaluate D-0502 in Subjects With ER+ Her2- Locally Advanced or Metastatic Breast Cancer is a Phase 3 clinical trial sponsored by InventisBio Co., Ltd studying Breast Cancer. This study tests if a new drug, D-0502, is as effective and safe as fulvestrant for advanced or metastatic breast cancer. It is for patients with ER-positive, HER2-negative breast cancer that has returned or spread after prior treatments. Participants will be randomly assigned to receive either D-0502 or fulvestrant. The study is open-label, meaning both patients and doctors will know which treatment is being given. The trial aims to enroll 640 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. Patients with ER-positive, HER2-negative breast cancer that has spread or cannot be removed by surgery. Must have had disease progression during or after endocrine therapy, or after 1-2 prior endocrine treatments. Must have at least one measurable tumor or evaluable bone lesions. Cannot have received prior treatment with similar drugs like fulvestrant, or more than 2 prior chemotherapy regimens. This trial is studying Breast Cancer, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The main goal is to see how long patients live without their cancer getting worse, measured by progression-free survival. The specific primary outcome measures are: Progression free survival (PFS) assessed by Independent Review Committee (IRC) (From enrollment to the end of treatment, up to 2 years). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.

Why This Trial Matters

This trial addresses a need for new treatment options for patients with advanced ER-positive, HER2-negative breast cancer who have progressed on existing therapies. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Breast Cancer, where improved treatment options are needed.

Investor Insight

This Phase III trial for a novel oral SERD/SERCA indicates a significant investment in a competitive market for advanced breast cancer treatments, with potential for a new oral option if successful. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage. The large enrollment target of 640 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor if D-0502 or fulvestrant is the right choice for you based on your medical history. Understand that you will be randomly assigned to one of the two treatments. Participation involves regular clinic visits for assessments, scans, and receiving the study drug. This trial is currently recruiting participants. The trial is being conducted at 2 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Full Eligibility Criteria

Inclusion Criteria:

* 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;

Exclusion Criteria:

* 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

Frequently Asked Questions

What is clinical trial NCT06954961?

NCT06954961 is a Phase 3 INTERVENTIONAL study titled "A Study to Evaluate D-0502 in Subjects With ER+ Her2- Locally Advanced or Metastatic Breast Cancer." It is currently recruiting and is sponsored by InventisBio Co., Ltd. The trial targets enrollment of 640 participants.

What conditions does NCT06954961 study?

This trial investigates treatments for Breast Cancer. The primary condition under study is Breast Cancer.

What treatments are being tested in NCT06954961?

The interventions being studied include: D-0502 (DRUG), Fulvestrant (DRUG). * Dosage form: Tablet * Administration route: Oral, once a day

What does Phase 3 mean for NCT06954961?

Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.

What is the current status of NCT06954961?

This trial is currently "Recruiting." It started on 2022-09-15. The estimated completion date is 2028-12-31.

Who is sponsoring NCT06954961?

NCT06954961 is sponsored by InventisBio Co., Ltd. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT06954961?

The trial aims to enroll 640 participants. The trial is currently recruiting and accepting new participants.

How is NCT06954961 designed?

This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.

What are the primary outcomes being measured in NCT06954961?

The primary outcome measures are: Progression free survival (PFS) assessed by Independent Review Committee (IRC) (From enrollment to the end of treatment, up to 2 years). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT06954961 being conducted?

This trial is being conducted at 2 sites, including Beijing, Beijing Municipality; Harbin, Heilongjiang (China).

Where can I find official information about NCT06954961?

The official record for NCT06954961 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06954961. This government database provides the most up-to-date and detailed information about the trial.

What is NCT06954961 testing in simple terms?

This study tests if a new drug, D-0502, is as effective and safe as fulvestrant for advanced or metastatic breast cancer. It is for patients with ER-positive, HER2-negative breast cancer that has returned or spread after prior treatments.

Why is this trial significant?

This trial addresses a need for new treatment options for patients with advanced ER-positive, HER2-negative breast cancer who have progressed on existing therapies. As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.

What are the potential risks of participating in NCT06954961?

Common side effects may include fatigue, nausea, and hot flashes. Potential risks include liver problems, bone density changes, and blood clots. As this is an open-label study, patients and doctors know which treatment is received, which may influence perceptions of side effects. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT06954961?

Ask your doctor if D-0502 or fulvestrant is the right choice for you based on your medical history. Understand that you will be randomly assigned to one of the two treatments. Participation involves regular clinic visits for assessments, scans, and receiving the study drug. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT06954961 signal from an investment perspective?

This Phase III trial for a novel oral SERD/SERCA indicates a significant investment in a competitive market for advanced breast cancer treatments, with potential for a new oral option if successful. This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.

What happens if the treatment in this trial doesn't work?

Participants will be randomly assigned to receive either D-0502 or fulvestrant. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.