Clinical trial NCT00289263: Maintenance Chemotherapy in Metastatic Breast Cancer
Official title: Maintenance Paclitaxel Vs Control After Anthracycline/Paclitaxel Combined First-Line Chemotherapy in Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Breast Cancer
Keywords: metastatic breast cancer
maintenance chemotherapy
Lead sponsor: MANTA 1 Study Italian Collaborative Group
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2006-02-09
Enrollment: 524
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Time to disease progression with maintenance paclitaxel versus observation
Secondary outcomes:
measure: Overall survival
measure: Toxicity
measure: Quality of live
measure: Conversion to a better response
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: Azienda Ospedaliera Pisana
state: PI
city: Bari
country: Italy
facility: Oncology Institute
city: Forli
country: Italy
facility: Morgagni-Pierantoni Hospital
city: Genoa
country: Italy
facility: National Cancer Research Institute
city: Potenza
country: Italy
facility: S. Carlo Hospital
city: Reggio Emilia
country: Italy
facility: Santa Maria Nuova Hospital
city: Rome
country: Italy
facility: University of Rome
Study officials:
affiliation: University of Modena, Italy
name: PierFranco Conte, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Morgagni-Pierantoni Hospital, Forli, Italy
name: Dino Amadori, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oncology Institute, Bari, Italy
name: Mario Delena, MD
role: PRINCIPAL_INVESTIGATOR
References: