Local therapy for hormone receptor-positive oligometastatic breast cancer

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 2 trial evaluates the effectiveness of local therapy combined with systemic therapy for patients with estrogen receptor/ progesterone receptor-positive oligometastatic breast cancer. Participants will be randomized to receive either local therapy, which may include surgery, radiotherapy, or radiofrequency ablation, alongside systemic therapy, or systemic therapy alone. The study aims to determine if the addition of local treatment improves progression-free survival compared to systemic therapy alone.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Female sex
* ≥ 18 years of age
* Histologically confirmed invasive breast cancer, with oligometastatic disease defined as one of the following criteria: 1) One to four bone lesions; 2) One to four lung and/ or hepatic lesions; 3) Distant metastasis limited to ipsilateral cervical lymph nodes; 4) Distant metastasis limited to contralateral axillary lymph nodes
* Oligometastatic sites amenable to treatment with a local therapy modality, including surgical resection, stereotactic radiotherapy, or radiofrequency ablation
* Estrogen receptor-positive and/ or progesterone receptor-positive breast cancer
* Partial response or stable disease after at least six months of systemic therapy for breast cancer
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Measurable or non-measuble disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
* Life expectancy of at least 12 weeks
* For women in childbearing age, negative pregnancy test until 21 days before the date of study enrollment.
* Signed informed consent form
* Disposition and aptitude to fulfill the study protocol during the study duration

Exclusion Criteria:

* HER2-positive breast cancer
* Progressive disease during the last systemic treatment received for metastatic disease
* Previous local therapy for distant metastasis
* Current or previous history of severe diseases, such as clinically relevant heart failure, acute myocardium infarction in the last six months, chronic obstructive lung disease, HIV infection, chronic active hepatitis B or C infection, current serious uncontrolled infections or other severe diseases that may impact patients' expected survival)
* Current or previous history of other invasive malignancy within the last five years, excluding non-melanoma skin cancer

Where it's running

• Icesp
  São Paulo, São Paulo, Brazil Recruiting

Study contacts

• Principal investigator: Renata C. Bonadio, MD — Instituto do Cancer do Estado de São Paulo
• Study coordinator: Renata C. Bonadio, MD
• Email: rrccbonadio@gmail.com
• Phone: +5511989554040

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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.