Clinical trial · Interventional
BREAST-10: Three-weekly Versus Weekly First-line Chemotherapy for Metastatic or Locally Advanced Breast Cancer
Phase III Multicenter Study of the Effects on Quality of Life of Three-weekly Versus Weekly First-line Chemotherapy for Metastatic or Locally Advanced Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Some chemotherapies, including docetaxel, are better tolerated and just as effective when giving the dose weekly rather than on an every three week basis. The purpose of this study is to compare 2 schedules of combination chemotherapy with docetaxel for the effects on quality of life. Standard every three week chemotherapy will be compared with weekly chemotherapy for metastatic or locally advanced breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| capecitabine | Drug | Capecitabine | ALIAS |
| docetaxel | Drug | Docetaxel | ALIAS |
| epirubicin | Drug | Epirubicin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- A
- description
- Three-weekly chemotherapy
- interventionNames
- Drug: docetaxel
- Drug: epirubicin
- Drug: capecitabine
- type
- EXPERIMENTAL
- label
- B
- description
- Weekly chemotherapy
- interventionNames
- Drug: docetaxel
- Drug: epirubicin
- Drug: capecitabine
Primary outcomes (1)
- measure
- quality of life
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histological diagnosis of breast cancer * Inoperable locally advanced or metastatic disease not yet treated with first-line chemotherapy * Age \< 70 years * ECOG performance status \< 2 * Written informed consent Exclusion Criteria: * Previous or concomitant malignant neoplasm (excluding adequately treated baso or spinocellular skin carcinoma or carcinoma in situ of the cervix) * Previous treatment with docetaxel * Symptomatic brain metastases * Neutrophil \< 2000/mm3, platelets \< 100,000/mm3, haemoglobin \< 10 g/dl * Creatinine \> 1.25 x the upper normal limits * GOT and/or GPT \> 1.25 x the upper normal limits in absence of hepatic metastases * GOT and/or GPT \> 2.5 x the upper normal limits in presence of hepatic metastases * Bilirubin \> 1.5 x the upper normal limit * Any concomitant pathology that would, in the investigator's opinion, contraindicate the use of the drugs in this study * Inability to provide informed consent * Inability to comply with follow-up
References
Publications (1)
- RESULTNuzzo F, Morabito A, Gravina A, Di Rella F, Landi G, Pacilio C, Labonia V, Rossi E, De Maio E, Piccirillo MC, D'Aiuto G, Thomas R, Rinaldo M, Botti G, Di Bonito M, Di Maio M, Gallo C, Perrone F, de Matteis A. Effects on quality of life of weekly docetaxel-based chemotherapy in patients with locally advanced or metastatic breast cancer: results of a single-centre randomized phase 3 trial. BMC Cancer. 2011 Feb 16;11:75. doi: 10.1186/1471-2407-11-75. PMID 21324184