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Maintenance Chemotherapy in Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT00289263
Recruitment Status : Unknown
Verified November 2003 by MANTA 1 Study Italian Collaborative Group.
Recruitment status was:  Active, not recruiting
First Posted : February 9, 2006
Last Update Posted : February 9, 2006
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Drug: Paclitaxel Phase 3

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 524 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Maintenance Paclitaxel Vs Control After Anthracycline/Paclitaxel Combined First-Line Chemotherapy in Metastatic Breast Cancer
Study Start Date : April 1998
Estimated Study Completion Date : October 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Paclitaxel
U.S. FDA Resources

Arms and Interventions


Outcome Measures

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

Secondary Outcome Measures :
  1. Overall survival
  2. Toxicity
  3. Quality of live
  4. Conversion to a better response

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00289263     History of Changes
Other Study ID Numbers: MANTA1
First Posted: February 9, 2006    Key Record Dates
Last Update Posted: February 9, 2006
Last Verified: November 2003

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
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action