ELDA: Elderly Breast Cancer - Docetaxel in Adjuvant Treatment

Phase 3

Completed

• Conditions: Breast Cancer
• Interventions: Drug: docetaxel; Drug: cyclophosphamide; Drug: methotrexate; Drug: 5-fluorouracil

• Registration Number: NCT00331097
• Lead Sponsor: National Cancer Institute, Naples

Brief Summary

The purpose of this study is to compare disease free survival of elderly breast cancer patients treated with standard adjuvant chemotherapy (CMF) versus experimental adjuvant chemotherapy (weekly docetaxel).

Detailed Description

Adjuvant combination chemotherapy, given after breast cancer surgery, has been established as the standard approach to reduce the risk of breast cancer recurrence in those patients at intermediate or high risk for recurrence. However, since elderly patients have been underrepresented in past clinical trials, the optimal adjuvant therapy for elderly patients at risk for recurrence has not yet been defined.

Docetaxel is one of the most active drugs for patients with metastatic breast cancer and several trials are evaluating its efficacy in the adjuvant setting. Administration of docetaxel on a weekly schedule is effective and well tolerated in women with metastatic breast cancer.

In this study, patients from ages 65 to 80 will be randomized to one of two treatment strategies:

* standard adjuvant chemotherapy with CMF (cyclophosphamide, methotrexate, and 5-fluorouracil given intravenously on days 1 and 8 of each cycle)

* experimental adjuvant chemotherapy with weekly docetaxel (given intravenously on days 1,8, and 15 of each cycle)

In both treatment strategies:

* 4 cycles of chemotherapy will administered for patients at least 10% positive for ER or PgR, and 6 cycles will administered for patients expressing \< 10% ER or PgR

* patients with any positive expression of ER or PgR will receive adjuvant hormonal therapy with tamoxifen (20mg/day for 5 years) after concluding chemotherapy

* adjuvant radiation therapy will be given to patients who are candidates at the conclusion of chemotherapy and within 6 months of surgery.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2003-07
• Study First Submitted: 2006-05-26
• Study First Submitted QC: 2006-05-26
• Study First Posted: 2006-05-29
• Primary Completion: 2014-05
• Study Completion: 2014-11
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

• Histologically confirmed invasive unilateral breast cancer
• Age > 65 and < 80 years
• Intermediate-high risk of recurrence according to St. Gallen criteria: ER negative and PgR negative, or axillary lymph node metastasis, or tumor size > 2 cm, or tumor grade 2 or 3 (intermediate or high)

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Exclusion Criteria

• Performance status >1
• Distant metastasis
• Concomitant malignancy or malignancy within previous 5 years (except basal cell or spinocellular skin cancer and in situ cervical cancer if they have been adequately treated
• Previous breast cancer treatment
• Neutrophils < 2000/mm3 or platelets < 100000/mm3 or haemoglobin < 10 g/dl
• Creatinine > 1.25 the upper normal limit
• GOT and-or GPT and/or bilirubin > 1.25 the upper normal limit
• Concomitant conditions that contraindicate the use of the drugs in the protocol
• Incapacity or refusal to provide informed consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	docetaxel	Weekly docetaxel
A	cyclophosphamide	Standard chemotherapy with CMF
A	methotrexate	Standard chemotherapy with CMF
A	5-fluorouracil	Standard chemotherapy with CMF

Primary Outcome Measures

Name	Time	Method
disease free survival	at 5 years

Secondary Outcome Measures

Name	Time	Method
toxicity	weekly
compliance	every 3 weeks
overall survival	at 5 years
quality of life	baseline and every 3 weeks during therapy

Trial Locations

Locations (8)

Azienda Ospedaliera G. Rummo; 🇮🇹 Benevento, BN, Italy

Policlinico Monteluce; 🇮🇹 Sant'Andrea delle Frate, PG, Italy

Università Federico II, Cattedra di Oncologia Medica; 🇮🇹 Napoli, Italy

Az. Osp. Treviglio - Caravaggio; 🇮🇹 Treviglio, Italy

Azienda Sanitaria S. Giuseppe Moscati; 🇮🇹 Monteforte Irpino, AV, Italy

Azienda Ospedaliera Cardarelli; 🇮🇹 Napoli, Italy

Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C; 🇮🇹 Napoli, Italy

Ospedale S. Luca ASL SA 3; 🇮🇹 Vallo della Lucania, Italy