Integration of 3D-conformal, local radiotherapy (3DCRT) to metastatic sites in a paclitaxel weekly chemotherapy regimen in oligometastatic breast cancer patients: A phase I- and randomised phase II-study

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 80

Inclusion Criteria

1. Women with histologically or cytologically confirmed, oligometastatic (stage IV) breast cancer, defined as: more than or equal to three metastatic lesions, or primary tumor and more than or equal to two metastatic lesions not amenable to curative surgery for medical or surgical reasons
2. Estrogen- and progesterone receptor negative status, hormone-refractory or rapid progressive disease
3. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) (except patients with metastatic lesions confided to the bones who may be included in case of non-measurable, but assessasble disease
4. Age 18 to 75 years, Performance Status (PS) zero to one
5. Adequate renal, hematological and hepatic function
6. Minimum estimated life expectancy three months
7. Written informed consent
8. Absence of any condition potentially hampering compliance with the study protocol and follow-up schedule

Exclusion Criteria

1. Patients with cerebral metastasis as well as metastasis in anantomic proximity to peripherapy nerves precluding the delivery of the planned radiochemotherapy
2. Malignant ascites, pericardial or pleural effusions
3. Concomitant malignancy (except basal cell skin carcinoma and carcinoma in situ of the uterine cervix)
4. Pregnant or lactating women, unclear contraception
5. Prior radiation to the metastatic sites
6. Prior treatment with taxanes
7. Known hypersensitivity to taxanes or cremophor EL
8. Patients with a history of grade III/IV peripheral neuropathy of any aetiology
9. Patients with diabetes mellitus and a peripheral neuropathy of any etiology

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-free-survival in both study arms, as measured by the one-year progression free survival rate

Secondary Outcome Measures

Name	Time	Method
<br> 1. Objective tumor response rate<br> 2. Toxicity<br> 3. Overall survival, as measured by 1-, 2-, and 3-year survival rates<br> 4. Clinical benefit (defined as the proportion of patients with stable disease [SD] >24 weeks, complete response [CR] and partial response [PR])<br> 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 in both study arms<br>

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