Treatment for HER2-negative breast cancer that is resistant to immune therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase II, open-label study evaluates the efficacy and safety of combining retinoic acid with immune checkpoint inhibitors in patients with metastatic HER2-negative breast cancer who have progressed after previous immune therapies. The study focuses on both luminal and triple-negative breast cancer subtypes, aiming to address the limited effectiveness of current immunotherapy options in these populations. Participants will receive a combination of retinoic acid, an anti-PD-1 antibody, and chemotherapy to assess potential improvements in treatment outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* ECOG Performance Status of 0, 1, or 2
* Metastatic or locally advanced, histologically confirmed luminal breast cancer (defined as: ER positive when immunohistochemistry shows \>1% positive tumor cells, PR positive when \>1% tumor cells are positive, and HER2 negative when scored as 0-1+ or when HER2 2+ shows no amplification by FISH or CISH) or triple negative breast cancer (defined as: ER negative when immunohistochemistry shows \<1% positive tumor cells, PR negative when \<1% tumor cells are positive, and HER2 negative when scored as 0-1+ or when HER2 2+ shows no amplification by FISH or CISH).
* Radiologic/objective evidence of recurrence or disease progression after immunotherapy (combined with targeted therapy or chemo ) for metastatic breast cancer (MBC)
* Adequate hematologic and end-organ function, laboratory test results, obtained within 14 days prior to initiation of study treatment.

For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures as outlined for each specific treatment arm

* Measurable disease according to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1)
* have the cognitive ability to understand the protocol and be willing to participate and to be followed up.

Exclusion Criteria:

* Symptomatic, untreated, or actively progressing CNS metastases
* Active or history of autoimmune disease or immune deficiency
* Significant cardiovascular disease
* History of malignancy other than breast cancer within 5 years prior to screening, with the exception of those with a negligible risk of metastasis or death
* Treatment with chemotherapy, radiotherapy, immunotherapy or surgery (outpatient clinic surgery excluded) within 3 weeks prior to initiation of study treatment.
* Pregnancy or breastfeeding, or intention of becoming pregnant during the study
* History of allergies to the drug components of this trial
* History of eosinophilosis or mastocytosis
* Patients who have been using oral steroid hormones for a long time will need to stop for 4 weeks if they have used them occasionally in the past

Where it's running

• Fudan University Shanghai Cancer Center
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Zhimin Shao, Professor
• Email: zhimingshao@yahoo.com
• Phone: 08664175590

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Giredestrant in ER-positive, HER2-negative early breast cancer: who tolerates it and sticks with treatment

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• Metronomic Oral Paclitaxel for Advanced HER2-Negative Breast Cancer

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• RGT-490 for adults with PIK3CA-mutated advanced solid tumors

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• Pre-surgery hormone therapy to lower positive margins in lobular breast cancer

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  Recruiting at 7 sites Phase 2 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07483307

• Radiation with anlotinib for HER2-negative breast cancer brain metastases

  This trial tests whether adding the drug anlotinib to stereotactic or whole-brain radiotherapy (with a microtubule inhibitor) helps people with HER2-negative breast cancer that has spread to the brain.

  Recruiting Phase 2 The First Affiliated Hospital with Nanjing Medical University · Nanjing · NCT07396454

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.