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Nanoparticle-based Paclitaxel vs Solvent-based Paclitaxel as Part of Neoadjuvant Chemotherapy for Early Breast Cancer (GeparSepto)

NCT01583426 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1229

Last updated 2020-08-06

No results posted yet for this study

Summary

Current guidelines as those from the AGO-Breast commission recommend for neoadjuvant breast cancer patients either a sequence of 4 cycles EC followed by 4 cycles of a taxane or 6 cycles of TAC based on previous large scale studies.

Treatment of patients with HER2-positive disease should include also simultaneous application of trastuzumab.

Solvent-based taxanes (paclitaxel, docetaxel) cause severe toxicities not only by the active agents itself but also by the solvents like cremophor. Nab-paclitaxel (Abraxane®) is a solvent-free formulation of paclitaxel encapsulated in albumin. It does not require premedication with corticosteroids or antihistamines to prevent the risk of solvent-mediated hypersensitivity reactions. This new formulation improves safety profile, allows higher dosing with shorter infusion duration, and produces higher tumor drug concentration.

As neoadjuvant treatment does not only allow to compare competing treatment approaches with a very high quality (homogenous treatment population, precise assessment of response by histological assessment), but also to identify predictive markers, this trial will compare weekly nab-paclitaxel with solvent-based paclitaxel at their currently optimal doses.

In case of HER2-positive tumor status patients receive Pertuzumab and Trastuzumab additionally.

Conditions

  • Tubular Breast Cancer Stage II
  • Mucinous Breast Cancer Stage II
  • Breast Cancer Female NOS
  • Invasive Ductal Breast Cancer
  • Tubular Breast Cancer Stage III
  • HER-2 Positive Breast Cancer
  • Inflammatory Breast Cancer Stage IV
  • Inflammatory Breast Cancer

Interventions

DRUG

nab-Paclitaxel

nab-Paclitaxel 125 mg/m² weekly for 12 weeks

DRUG

Paclitaxel

Paclitaxel 80 mg/m² weekly for 12 weeks

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY

  • Roche Pharma AG

    collaborator INDUSTRY

  • GBG Forschungs GmbH

    lead OTHER

Principal Investigators

  • Michael Untch, Prof MD · AGO, ASCO, DKG

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01583426 on ClinicalTrials.gov