Phase 3 Breast Cancer Trial, Recruiting NCT06954961 Sponsor: InventisBio Co., Ltd Condition: Breast Cancer
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Phase 3 Breast Cancer Trial, Recruiting

NCT06954961
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have been confirmed by pathology (lab testing of tissue) to have breast cancer that is ER-positive (driven by the hormone oestrogen) and HER2-negative (a specific protein is not overactive).
  • People whose breast cancer has either spread to nearby areas and cannot be surgically removed (locally advanced), or has spread to other parts of the body (metastatic), and whose cancer came back during or after hormone-blocking treatment given after surgery, or whose cancer has gotten worse after 1 to 2 rounds of hormone-based treatment.
  • People who have at least one tumour area that can be measured by CT or MRI scan using standard criteria; people with certain types of bone lesions (areas of bone affected by cancer) may also be eligible if no other measurable areas are present.
  • People whose doctors estimate they are expected to live at least 12 weeks or more.

Who may not be able to join:

  • People who have cancer that has spread to the brain and is currently causing symptoms, is unstable, or is getting worse (people with a history of brain metastases that have been stable for at least 4 weeks after their last brain radiation treatment, with no signs of progression on a brain scan, may still be considered).
  • People who have previously received more than 2 rounds of chemotherapy for locally advanced or metastatic breast cancer.
  • People who, in the treating doctor's judgment, are not suitable for hormone-based therapy — for example, those with uncontrolled fluid build-up around the lungs, in the abdomen, or around the heart.
  • People who have other serious health conditions — such as significant heart, lung, or neurological (nervous system) disease — that the doctor believes could increase the risk of harmful side effects.
  • People who have previously been treated with a specific class of drugs known as SERDs or SERCAs, which are a type of oestrogen receptor-blocking medication. Examples include fulvestrant and several others (confirm with trial site for the full list).
  • People who are currently pregnant or breastfeeding.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 8 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Binghe Xu, MD, Cancer Hospital

Phone: 8615821378026

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
InventisBio Co., Ltd
Registry
ClinicalTrials.gov
Start date
15 September 2022
Est. completion
30 November 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Progression free survival (PFS) assessed by Independent Review Committee (IRC)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 8 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov