Local therapy for hormone receptor-positive oligometastatic breast cancer
Local Therapy for Hormone Receptor-positive Oligometastatic Breast Cancer - a Phase II Randomized Trial
PHASE2 · Instituto do Cancer do Estado de São Paulo · NCT04698252
This study tests if adding local treatments like surgery or radiation to standard therapy can help people with a specific type of breast cancer live longer without their cancer getting worse.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 74 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Instituto do Cancer do Estado de São Paulo (other) |
| Locations | 1 site (São Paulo, São Paulo) |
| Trial ID | NCT04698252 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with hormone receptor-positive oligometastatic breast cancer who have shown a partial response or stable disease after at least six months of systemic therapy.
Not a fit: Patients with non-hormone receptor-positive breast cancer or those with extensive metastatic disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve progression-free survival for patients with oligometastatic breast cancer.
How similar studies have performed: Other studies have shown promising results with local therapies for oligometastatic cancers, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
São Paulo, São Paulo
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer, Oligometastasis, Hormone Receptor Positive, Surgery, Radiotherapy, Radiofrequency ablation