ELDA: Elderly Breast Cancer - Docetaxel in Adjuvant Treatment

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute, Naples
ClinicalTrials.gov Identifier:
NCT00331097
First received: May 26, 2006
Last updated: August 1, 2013
Last verified: August 2013
  Purpose

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).


Condition Intervention Phase
Breast Cancer
Drug: docetaxel
Drug: cyclophosphamide
Drug: methotrexate
Drug: 5-fluorouracil
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Adjuvant Chemotherapy in Elderly Patients With Breast Cancer: Weekly Docetaxel vs. CMF

Resource links provided by NLM:


Further study details as provided by National Cancer Institute, Naples:

Primary Outcome Measures:
  • disease free survival [ Time Frame: at 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • toxicity [ Time Frame: weekly ] [ Designated as safety issue: No ]
  • compliance [ Time Frame: every 3 weeks ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: baseline and every 3 weeks during therapy ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: at 5 years ] [ Designated as safety issue: No ]

Enrollment: 300
Study Start Date: July 2003
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Standard chemotherapy with CMF
Drug: cyclophosphamide
600 mg/m2 intravenously days 1, 8 every 28 days
Drug: methotrexate
40 mg/m2 intravenously days 1 and 8 every 28 days
Drug: 5-fluorouracil
600 mg/m2 intravenously days 1 and 8 every 28 days
Experimental: B
Weekly docetaxel
Drug: docetaxel
35 mg/m2 intravenously on days 1, 8, and 15 every 28 days

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.
  Eligibility

Ages Eligible for Study:   65 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00331097

Locations
Italy
Azienda Sanitaria S. Giuseppe Moscati
Monteforte Irpino, AV, Italy
Azienda Ospedaliera G. Rummo
Benevento, BN, Italy
Policlinico Monteluce
Sant'Andrea delle Frate, PG, Italy
Azienda Ospedaliera Cardarelli
Napoli, Italy, 80131
Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C
Napoli, Italy, 80131
Università Federico II, Cattedra di Oncologia Medica
Napoli, Italy
Az. Osp. Treviglio - Caravaggio
Treviglio, Italy
Ospedale S. Luca ASL SA 3
Vallo della Lucania, Italy
Sponsors and Collaborators
National Cancer Institute, Naples
Investigators
Principal Investigator: Andrea De Matteis, M.D. NCI Naples, Division of Medical Oncology C
Principal Investigator: Giuseppe D'Aiuto, M.D. NCI Naples, Division of Surgical Oncology A
Principal Investigator: Francesco Perrone, M.D., Ph.D. NCI Naples, Clinical Trials Unit
  More Information

Publications:
Responsible Party: National Cancer Institute, Naples
ClinicalTrials.gov Identifier: NCT00331097     History of Changes
Other Study ID Numbers: ELDA
Study First Received: May 26, 2006
Last Updated: August 1, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by National Cancer Institute, Naples:
elderly
adjuvant therapy
intermediate risk
high risk

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Docetaxel
Cyclophosphamide
Methotrexate
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Antimetabolites, Antineoplastic
Antimetabolites
Dermatologic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on October 01, 2014