Phase 2 Breast Cancer Trial, Recruiting NCT07616427 Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University Condition: Breast Cancer
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Phase 2 Breast Cancer Trial, Recruiting

NCT07616427
Recruiting Phase 2

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 are willing to take part voluntarily, understand what the study involves, and are able to follow all study procedures
  • Women aged 18 to 75 years
  • People who have been diagnosed with breast cancer confirmed by tissue testing, where the cancer is hormone receptor-positive (ER greater than 10%) and HER2-positive, and is either early-stage or locally advanced
  • People whose cancer has been staged as Stage I, II, or III using a standard medical staging system
  • Women who have not yet gone through menopause and who are receiving treatment to suppress ovarian function
  • People whom the treating doctor considers suitable for a type of hormone-blocking treatment called an aromatase inhibitor
  • People whose cancer can be measured or assessed on scans according to standard criteria
  • People who are generally well and able to carry out daily activities with no or minimal limitations (confirm with trial site)
  • People who are able to swallow capsules
  • People whose blood counts, liver, kidney, and heart function all meet certain minimum levels as assessed by blood tests and heart scans (confirm with trial site for specific values)

Who may not be able to join:

  • People who are currently taking part in another clinical trial involving an experimental treatment, or another study considered incompatible with this one
  • People with cancer in both breasts, inflammatory breast cancer, or occult breast cancer
  • People with a history of uncontrolled seizures or a disease affecting the brain or central nervous system
  • People who have had another type of cancer in the past 5 years
  • People who are pregnant or breastfeeding
  • People with a known serious allergic reaction to any of the study drugs
  • People with serious ongoing health conditions such as severely uncontrolled high blood pressure, uncontrolled diabetes, or an active infection (note: people with adequately controlled high blood pressure may still be considered)
  • People who have had significant fluid build-up around the lungs, heart, or abdomen that has needed repeated draining or medical treatment in the 2 weeks before starting the study
  • People who have had a heart attack within the past 6 months, or who have certain serious heart rhythm problems, severe heart failure, reduced heart pumping function, or significant fluid around the heart or lungs requiring treatment
  • People who have difficulty swallowing, active gut or digestive disease, a history of major bowel or stomach surgery, or any condition that may affect how the body absorbs medication
  • People with active hepatitis B, active hepatitis C, syphilis (unless confirmed as fully inactive), known HIV infection, or a positive HIV test result
  • People who have received major surgery, radiotherapy, immunotherapy, certain antibody-based cancer treatments, or other systemic cancer treatments within 28 days before starting the study
  • People who have had or are planning to have an organ transplant or bone marrow transplant
  • People with a known history of psychiatric substance misuse or drug addiction
  • People whom the treating doctor considers unsuitable for any other reason

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 22 July 2026
Phase 2: approximately ~30% 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

Phone: 15868131018

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 2
Registry
ClinicalTrials.gov
Start date
20 May 2026
Est. completion
20 May 2028

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Total Pathological Complete Response (tpCR) Rate: ypT0/Tis, ypN0

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: 22 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