Inoperable, hormone-responsive, oligometastatic breast cancer Cancer Malignant neoplasm of breast
Conditions
Interventions
Endocrine treatment with letrozole 2.5 mg po (orally) daily in both study arms, additional local 3DCRT (50 Gy) to metastatic lesions in the experimental arm
Sponsors
Martin-Luther-University (Germany)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Postmenopausal women with histologically or cytologically confirmed, oligometastatic breast cancer, defined as: =3 metastatic lesions, or primary tumor and =2 metastatic lesions not amenable to curative surgery for medical or surgical reasons 2. No prior endocrine therapy for metastatic disease 3. Estrogen receptor and/or progresterone receptor positive status or with both receptors unknown 4. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) (except patients with metastatic lesions confined to the bones who may be included in case or non-measurable but assessable disease) 5. Age >18 years, Eastern Cooperative Oncology Group (ECOG) 0-2 6. Adequate hematological, renal and hepatic function
Exclusion criteria
Exclusion criteria: 1. Central nervous system (CNS) metastasis or other metastasis in anatomic proximity to peripheral nerves precluding the delivery of the planned radiotherapy 2. Patients requiring immediate treatment with chemotherapy due to extensive visceral involvement or marked clinical symptoms 3. Malignant ascites, pericardial or pleural effusions, malignant infiltration of the bone marrow 4. Malabsorption syndrome or other uncontrolled medical conditions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival as measured by the one-year progression-free survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Objective tumor response rate 2. Toxicity 3. 1-, 2-, 3-year survival rates 4. Clinical benefit (defined as proportion of patients with stable disease [SD] >24 weeks, complete response [CR] and partial response [PR]) 5. Quality of life, as measured by European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaires (QLQ) C30 and BR-23 | — |
Countries
Germany
Outcome results
None listed