Could two new drugs boost chemo success in HER2-Low breast cancer?
NCT ID NCT07317778
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase II trial tests whether adding the drugs SHR-A1811 and/or adebrelimab to standard chemotherapy can improve outcomes for people with HR-positive, HER2-low early-stage breast cancer. About 249 participants will receive either chemo alone, chemo plus adebrelimab, or a sequence of SHR-A1811, adebrelimab, and chemo before surgery. The main goal is to see if these combinations lead to a higher rate of complete tumor disappearance (pathological complete response) at the time of surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SHR-A1811 (Trastuzumab Rezetecan) and Adebrelimab (PD-L1 inhibitor)
- What this could lead to
- If successful, this could lead to a more effective neoadjuvant treatment for HR+/HER2-low early breast cancer, potentially increasing the chance of a complete response before surgery.
- What could go wrong
- This is an early phase II trial with a moderate size (249 participants). The combination may not improve outcomes over standard chemo and could have added side effects. Results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 249 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2033
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * ECOG score: 0-1; * Pathologically confirmed invasive breast cancer, with tumor stage T1c-T2, cN1-2 or T3-4 cN0-2; * HR positive/HER2 low expression(defined as HER2 IHC 1+/2+, FISH negative); * Known PD-L1 expression status, or sufficient tumor tissue for PD-L1 testing; * Sufficient organ function * Female patients who have not undergone menopause or sterilization, accept for abstain from sexual activity or use an effective contraceptive method during the treatment period and at least 7 months after the last administration of the study medication; * Voluntarily participate and sign the informed consent form. Exclusion Criteria: * Inflammatory breast cancer; * Previously received anti-tumor therapy or radiotherapy for any malignant tumor(not including cured cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma); * Concurrently received anti-tumor therapy in other clinical trials, including endocrine therapy, bisphosphonate therapy or immunotherapy; * Within 4 weeks before enrollment, underwent major surgical procedures unrelated to breast cancer, or the patient has not fully recovered from such procedures; * Had clinically significant pulmonary diseases, including but not limited to interstitial pneumonia, pneumonia, pulmonary fibrosis and radiation pneumonia (except for radiological changes that do not require treatment), or was found to have such diseases during the screening period; * Had any cardiac diseases, including: (1) Severe / unstable angina pectoris; (2) Requires drug treatment or has clinically significant arrhythmia; (3) Had a myocardial infarction within 6 months before enrollment; (4) Has symptomatic congestive heart failure with NYHA grade ≥ II; (5) Any other heart diseases judged by the researcher as not suitable for participation in this trial; * Known to have had an allergic history to the components of the drug in this protocol; have a history of immunodeficiency, including positive HIV test, or have other acquired or congenital immune deficiency diseases, or have a history of organ transplantation; * Had severe comorbidities or other conditions that would interfere with the planned treatment, or any other situation that the researcher considered the patient was not suitable for participation in this study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Cancer Center/Cancer hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, 100021, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can treating less breast tissue mean fewer radiation side effects?
- Gene test may Fine-Tune breast cancer therapy for younger women
- Can adding pyrotinib shrink HER2-Positive breast tumors before surgery?
- Exercise during chemo: a new weapon to preserve strength?
- Could a smartphone program ease Chemo's emotional toll?
- Could fewer heart tests be safer for breast cancer patients?