Can an immunotherapy combo rescue breast cancers that shrug off chemo?

NCT ID NCT07782840

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Female participants only

Healthy volunteers

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

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

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