Can an immunotherapy combo rescue breast cancers that shrug off chemo?
NCT ID NCT07782840
First seen Aug 24, 2026 · Last updated Aug 27, 2026 · Updated 3 times
Summary
This trial tests whether adding an experimental immunotherapy drug (QL1706) to standard hormone therapy can shrink tumors in people with a common type of breast cancer (HR-positive, HER2-negative) that did not respond well to initial chemotherapy. About 40 participants whose tumors shrank less than 40% after two rounds of chemo will be randomly assigned to receive either hormone therapy alone or hormone therapy plus QL1706. The study measures how often tumors shrink, whether they disappear completely, and how safe the combination is.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Iparomlimab and tuvonralimab (QL1706) combined with an aromatase inhibitor and a CDK4/6 inhibitor
- What this could lead to
- If adding QL1706 to endocrine therapy improves tumor shrinkage, it could offer a new treatment option for breast cancer patients who don't respond well to chemotherapy.
- What could go wrong
- This is a small, early-phase trial, so results may not apply broadly. Adding an immunotherapy drug can also increase the risk of immune-related side effects.
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 40 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
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: 1. Female participants aged 18 to 75 years. 2. Histologically or pathologically confirmed HR-positive/HER2-negative early or locally advanced breast cancer, classified as stage IIB-IIIC, with a poor response to two cycles of neoadjuvant TAC chemotherapy. Chemotherapy sensitivity is defined as a reduction in tumor size of at least 40% on magnetic resonance imaging (MRI), whereas a poor response is defined as a reduction in tumor size of less than 40%. 3. At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). 4. No prior antitumor treatment other than the two cycles of neoadjuvant TAC chemotherapy specified in this study, including no prior immune checkpoint inhibitor therapy. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 6. Life expectancy of at least 12 weeks. 7. No coagulation abnormalities. 8. Normal cardiac function, a normal electrocardiogram, and a left ventricular ejection fraction of at least 55%. 9. Willingness to provide tumor tissue and/or blood samples at baseline and after treatment for biomarker analyses. Participants with insufficient tumor tissue or those unwilling to provide biological samples may be enrolled only with the investigator's approval. 10. Adequate major organ function, as defined by the following laboratory criteria: absolute neutrophil count greater than 1.5 × 10\^9/L; platelet count greater than 100 × 10\^9/L; hemoglobin greater than 100 g/L; total serum bilirubin less than 1.5 × the upper limit of normal (ULN); alanine aminotransferase and aspartate aminotransferase less than 3 × ULN; and serum creatinine no greater than 1.5 × ULN. 11. Ability to understand and comply with the study requirements and willingness to provide written informed consent. Exclusion Criteria: 1. Known hypersensitivity to any study drug or any of its excipients. 2. Inflammatory breast cancer, bilateral breast cancer, or advanced breast cancer with distant metastases. 3. A history of another malignancy within the past 5 years, except for malignancies treated with curative intent. 4. Serious concomitant diseases, including extensive interstitial pneumonitis requiring pharmacological treatment; active or uncontrolled infection, including tuberculosis or human immunodeficiency virus infection; decompensated liver disease; active hepatitis; active bleeding; a history of cerebrovascular events or pulmonary embolism; active, known, or suspected autoimmune disease; or an active infection currently requiring systemic anti-infective therapy. 5. Active brain metastases or leptomeningeal metastases, unless the metastases have been treated and are stable. 6. Pregnancy, planned pregnancy, or breastfeeding. 7. Any other condition that, in the investigator's opinion, makes the participant unsuitable for enrollment.
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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 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.
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Other studies related to the condition(s) this trial covers.
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