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Maintenance Chemotherapy in Metastatic Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2003 by MANTA 1 Study Italian Collaborative Group.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
MANTA 1 Study Italian Collaborative Group
ClinicalTrials.gov Identifier:
NCT00289263
First received: February 8, 2006
Last updated: NA
Last verified: November 2003
History: No changes posted
  Purpose

This is a randomized, prospective and multicenter phase III study. Two-hundred-sixty-two (262) patients on each arm will be recruited in the study.


Condition Intervention Phase
Breast Cancer
 Drug: Paclitaxel
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Maintenance Paclitaxel Vs Control After Anthracycline/Paclitaxel Combined First-Line Chemotherapy in Metastatic Breast Cancer

Resource links provided by NLM:

Drug Information available for: Paclitaxel
U.S. FDA Resources

Further study details as provided by MANTA 1 Study Italian Collaborative Group:

Primary Outcome Measures:
  • Time to disease progression with maintenance paclitaxel versus observation

Secondary Outcome Measures:
  • Overall survival
  • Toxicity
  • Quality of live
  • Conversion to a better response

Estimated Enrollment: 524
Study Start Date: April 1998
Estimated Study Completion Date: October 2003
Detailed Description:

The primary objective is time to disease progression. All patients must be treated with first line chemotherapy, consisting of one of the following regimens: a) ET (epirubicin 90 mg/sqm day 1 plus paclitaxel 200 mg/sqm (3 hour infusion) day 1, or b) AT (doxorubicin 50 mg/sqm day 1 plus paclitaxel 200 mg/sqm (3 hour infusion) day 2, administered on a 3 weekly schedule.

Patients with complete response, partial response or stable disease are eligible for MANTA1 study.

The expected median progression free survival of metastatic breast cancer patients who achieve a disease control after first line chemotherapy was estimated to be 10 months. The minimal improvement, justifying the adoption of maintenance paclitaxel, was estimated to be at least 3 months. With 262 eligible patients on each arm, the trial will have a power of 80% to detect a 30% improvement in median progression free survival, testing at the two-sided .05 significance level.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent.
  • Patients with metastatic breast cancer in response or stable disease after six to eight courses of first line induction chemotherapy treatment
  • Measurable and/or evaluable disease
  • Performance status ECOG 0, 1, 2.
  • Normal cardiac function, confirmed by left ventricular ejection fraction (LVEF).

Exclusion Criteria:

  • Presence of peripheral neuropathy > grade 2 by NCI Common Toxicity Criteria (NCI-CTC) following induction chemotherapy
  • Adjuvant taxane-based therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00289263

Locations
Italy
Azienda Ospedaliera Pisana
Pisa, PI, Italy, 56100
Oncology Institute
Bari, Italy, 70010
Morgagni-Pierantoni Hospital
Forli, Italy, 47100
National Cancer Research Institute
Genoa, Italy
S. Carlo Hospital
Potenza, Italy
Santa Maria Nuova Hospital
Reggio Emilia, Italy
University of Rome
Rome, Italy
Sponsors and Collaborators
MANTA 1 Study Italian Collaborative Group
Bristol-Myers Squibb
Investigators
Principal Investigator: PierFranco Conte, MD University of Modena, Italy
Principal Investigator: Dino Amadori, MD Morgagni-Pierantoni Hospital, Forli, Italy
Principal Investigator: Mario Delena, MD Oncology Institute, Bari, Italy
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00289263     History of Changes
Other Study ID Numbers: MANTA1
Study First Received: February 8, 2006
Last Updated: February 8, 2006
Health Authority: Italy: Ministry of Health

Keywords provided by MANTA 1 Study Italian Collaborative Group:
metastatic breast cancer
maintenance chemotherapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Tubulin Modulators
 Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013