Maintenance Chemotherapy in Metastatic Breast Cancer

Maintenance Paclitaxel Vs Control After Anthracycline/Paclitaxel Combined First-Line Chemotherapy in Metastatic Breast Cancer

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00289263

Enrollment

524

Registered

2006-02-09

Start date

1998-04-30

Completion date

2003-10-31

Last updated

2006-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

metastatic breast cancer, maintenance chemotherapy

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.

Interventions

DRUGPaclitaxel

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Time to disease progression with maintenance paclitaxel versus observation	—

Secondary

Measure	Time frame
Overall survival	—
Toxicity	—
Quality of live	—
Conversion to a better response	—

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026