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โ† Trials
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Local Therapy for ER/PR-positive Oligometastatic Breast Cancer

RecruitingPhase 2Ages 18 Years - anyFemaleInstituto do Cancer do Estado de Sรฃo Paulo
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In plain words

What the trial is, and whether it could suit you

Randomized phase 2 trial to evaluate the efficacy of local therapy for oligometastasis from ER/PR-positive breast cancer. The study hypothesis is that local therapy in addition to systemic therapy improves progression-free survival in comparison with systemic therapy alone.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Female sex * โ‰ฅ 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
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What it tests

  • Radiotherapy
  • Surgery
  • Radiofrequency ablation
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Where

1 site
ICESP
Sรฃo Paulo, Brazil
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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