Preoperative Treatment of Breast Cancer With Two Different Sequential Treatment Regimens

Lilly logo

Lilly

Status and phase

Completed
Phase 2

Conditions

Breast Cancer

Treatments

Drug: docetaxel
Drug: pemetrexed
Drug: cyclophosphamide
Drug: doxorubicin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00149214
7113
H3E-MC-S080 (Other Identifier)

Details and patient eligibility

About

An open-label randomized Phase II study in order to explore two different sequential anthracycline-based neoadjuvant treatment regimens in female patients with primary, operable breast cancer (T2-T4/N0-2/M0).

Enrollment

257 patients

Sex

Female

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Histologically confirmed diagnosis of primary early breast cancer, tumor size greater than or equal to 2 centimeters (cm), of Stages T2-T4/N0-2.
  • Performance status 0-2 Eastern Cooperative Oncology Group (ECOG).
  • Adequate organ function (bone marrow, hepatic, renal, cardiac).

Exclusion criteria

  • Prior anthracyclines as part of prior anticancer therapy.
  • Concurrent antitumor therapy.
  • Second primary malignancy.
  • Serious concomitant systemic disorder.

Pre-existing sensorial or motor neuropathy

Grade 1.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

257 participants in 2 patient groups

A: Pemetrexed Plus Doxorubicin, Followed by Docetaxel
Experimental group
Treatment:
Drug: doxorubicin
Drug: docetaxel
Drug: pemetrexed
B: Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel
Active Comparator group
Treatment:
Drug: doxorubicin
Drug: cyclophosphamide
Drug: docetaxel

Trial contacts and locations

11

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems