ELDA: Elderly Breast Cancer - Docetaxel in Adjuvant Treatment

Breast Cancer Clinical Trial

Official title:

Adjuvant Chemotherapy in Elderly Patients With Breast Cancer: Weekly Docetaxel vs. CMF

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00331097
• Other study ID #: ELDA
• Status: Completed
• Phase: Phase 3
• First received: May 26, 2006
• Last updated: March 27, 2017
• Start date: July 2003
• Est. completion date: November 2014

Study information

• Verified date: March 2017
• Source: National Cancer Institute, Naples
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: November 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 65 Years to 80 Years

Eligibility

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)

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• docetaxel
35 mg/m2 intravenously on days 1, 8, and 15 every 28 days
• cyclophosphamide
600 mg/m2 intravenously days 1, 8 every 28 days
• methotrexate
40 mg/m2 intravenously days 1 and 8 every 28 days
• 5-fluorouracil
600 mg/m2 intravenously days 1 and 8 every 28 days

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera G. Rummo	Benevento	BN
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	Università Federico II, Cattedra di Oncologia Medica	Napoli
Italy	Policlinico Monteluce	Sant'Andrea delle Frate	PG
Italy	Az. Osp. Treviglio - Caravaggio	Treviglio
Italy	Ospedale S. Luca ASL SA 3	Vallo della Lucania

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Naples

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Nuzzo F, Morabito A, De Maio E, Di Rella F, Gravina A, Labonia V, Landi G, Pacilio C, Piccirillo MC, Rossi E, D'Aiuto G, Thomas R, Gori S, Colozza M, De Placido S, Lauria R, Signoriello G, Gallo C, Perrone F, de Matteis A. Weekly docetaxel versus CMF as adjuvant chemotherapy for elderly breast cancer patients: safety data from the multicentre phase 3 randomised ELDA trial. Crit Rev Oncol Hematol. 2008 May;66(2):171-80. Epub 2007 Dec 21. — View Citation

Perrone F, Nuzzo F, Di Rella F, Gravina A, Iodice G, Labonia V, Landi G, Pacilio C, Rossi E, De Laurentiis M, D'Aiuto M, Botti G, Forestieri V, Lauria R, De Placido S, Tinessa V, Daniele B, Gori S, Colantuoni G, Barni S, Riccardi F, De Maio E, Montanino A — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease free survival		at 5 years
Secondary	toxicity		weekly
Secondary	compliance		every 3 weeks
Secondary	quality of life		baseline and every 3 weeks during therapy
Secondary	overall survival		at 5 years