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Completed

NCT Number: NCT00149214

Preoperative Treatment of Breast Cancer With Two Different Sequential Treatment Regimens

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).

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Baden-Baden, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pemetrexed

Drug

500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4)

Other names: LY231514, Alimta

Cyclophosphamide

Drug

600 mg/m2, intravenous (IV), every 21 days, 4 cycles (1-4)

Doxorubicin

Drug

60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4)

docetaxel

Drug

100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)

Primary outcomes

  1. Number of Participants With a Pathological Complete Response

    Time frame: surgery after eight 21-day cycles of chemotherapy

    pathological assessment of tissue removed during surgery to determine if tumor tissue is still present after chemotherapy

Secondary outcomes

  1. Number of Participants With a Clinical Tumor Response After the First Sequence of Chemotherapy

    Time frame: Cycles 1-4 (21-day cycles)

    The number of participants with a clinical tumor response based on measurement of tumor size after the first sequence of chemotherapy, without a second confirmatory tumor measurement, per protocol.

  2. Number of Participants With a Clinical Tumor Response After the Second Sequence of Chemotherapy

    Time frame: Cycles 5-8 (21-day cycles)

    The number of participants with a clinical tumor response based on measurement of tumor size after the second sequence of chemotherapy, without a second confirmatory tumor measurement required, per protocol.

  3. Number of Patients With Histologically Negative Axillary Lymph Node Status at Surgery

    Time frame: surgery after eight 21-day cycles of chemotherapy

    Histologically negative is defined as no malignant cells present in the axillary lymph nodes during surgery.

  4. Disease-free Survival

    Time frame: baseline through post surgery, follow-up for 3 years post-surgery (up to 5.2 years after randomization)

    Disease-free survival is defined as the time from date of study enrollment (randomization) to first date of progressive disease (PD) or death from any cause. PD per Response Evaluation Criteria In Solid Tumors (RECIST) criteria is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. For patients not known to have died as of the data cut-off date and who do not have progressive disease, disease-free survival was censored at the last contact date.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Randomized Phase 2 Trial of Doxorubicin Plus Pemetrexed Followed by Docetaxel, Versus Doxorubicin Plus Cyclophosphamide Followed by Docetaxel, as Neoadjuvant Treatment for Early Breast Cancer

Important dates

Study start
2005
Primary completion
2008
Study completion
2011
First posted
Sep 8, 2005
Registry last updated
Mar 21, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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