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Completed

NCT Number: NCT00670878

Studying the Benefits of Adjuvant Sequential vs. Combined Taxane Based Chemotherapy, Followed by Different Biological Treatment Strategies in Early, HER2-positive Breast Cancer

This is an open-label, multicenter randomized controlled, Phase III study comparing the disease free survival after randomisation in patients treated with 3 cycles of Epirubicin-Fluorouracil-Cyclophosphamide (FEC)-chemotherapy, followed by 3 cycles of Docetaxel (D)-chemotherapy versus 3 cycles of Epirubicin-Fluorouracil- Cyclophosphamide (FEC), followed by 3 cycles of Gemcitabine-Docetaxel(DG)- chemotherapy. Patients will be required to have HER2-neu positive disease and histopathological proof of axillary lymph node metastases (pN1-3) or high risk node negative, defined as: pT>=2 or histopathological grade 3, or age <= 35 or negative hormone receptor', but are not allowed to have evidence of distant disease. Patients will have to be entered into the study no later than 6 weeks after complete resection of the primary tumor. No other antineoplastic treatment other than surgical treatment, the defined cytotoxic and endocrine treatment and radiotherapy will be allowed prior to study entry and during the course of the study.

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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 and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Frauenklinik der Universität München Campus Innenstadt

Munich, 80337, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Primary epithelial invasive carcinoma of the breast pT1-4, pN0-3, M0
  • Evidence of HER2-neu overexpressing (IHC +++) or amplifying (FISH +) tumor
  • Histopathological proof of axillary lymph node metastases (pN1-3) or high risk node negative, defined as at least two criteria of the following: 'pT³2, histopathological grade 3, age £ 35, negative hormone receptor'
  • Complete resection of the primary tumor with margins of resection free of invasive carcinoma not more than 6 weeks ago
  • Females >= 18 years of age
  • Performance Status <2 on ECOG-Scale
  • Adequate bone marrow reserve: leucocytes ³ 3.0 x 109/l and platelets ³ 100 x 109/l
  • Bilirubin within one fold of the reference laboratory's normal range, ASAT (SGOT), ALAT (SGPT) and AP within 1,5 fold of the reference laboratory's normal range for patients
  • Intention of regular follow up visits for the duration of the study
  • Ability to understand the nature of the study and to give written informed consent
  • Women of childbearing potential must agree to use an effective method of contraception (Pearl-Index < 1, e.g. , intrauterine devices or sterilization) during treatment and for at least 6 months thereafter.

Exclusion criteria

  • Inflammatory breast cancer
  • Previous or concomitant cytotoxic or other systemic antineoplastic treatment which is not part of this study
  • A second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin)
  • Cardiomyopathy with impaired ventricular function (NYHA > II), cardiac arrhythmias influencing LVEF and requiring medication, history of myocardial infarction or angina pectoris within the last 6 months, or arterial hypertension not being controlled by medication
  • Any known hypersensitivity reaction against docetaxel, epirubicin, cyclophosphamide, gemcitabine or any other medication included in the study protocol. The contraindication, warning notices and measures of precaution of the products, as notified in the product information, have to be respected
  • Instable diabetes mellitus, out of sufficient medical control
  • Use of any investigational agent within 3 weeks prior to inclusion
  • Patients in pregnancy or breast feeding (in premenopausal women contraception has to be assured)

Treatment and study plan

3 x FEC 3 x DOC / Gemcitabine

Drug

3 cycles of 5-Fluorouracil 500 mg/m² i.v. body surface area and Epirubicin 100 mg/m² i.v. and Cyclophosphamide 500 mg/m² i.v., (FEC100), each administered on day 1, repeated on day 22, subsequently followed by 3 cycles of Docetaxel 75 mg/m² body surface area i.v. (D), and Gemcitabine 1000 mg/m² i.v. (30 min infusion) (G), administered on day 1, followed by Gemcitabine 1000 mg/m² i.v. (30 min infusion) on day 8, repeated on day 22

3 x FEC 3 x DOC

Drug

3 cycles of 5-Fluorouracil 500 mg/m² i.v. body surface area and Epirubicin 100 mg/m² i.v. and Cyclophosphamide 500 mg/m² i.v., (FEC100), each administered on day 1, repeated on day 22, subsequently followed by 3 cycles of Docetaxel 100 mg/m² body surface area i.v. (D), administered on day 1, repeated on day 22

Primary outcomes

  1. Disease free survival

    Time frame: 5 y

Secondary outcomes

  1. Overall survival time after randomization

    Time frame: 5 Y

  2. Distant disease free survival

    Time frame: 5 Y

  3. Toxicity

    Time frame: 5 Y

  4. Changes in quality of life over time as defined by EORTC QLQ-C30 and QLQBR23 questionnaire

    Time frame: 5 Y

  5. Skeletal related events

    Time frame: 5 Y

  6. Incidence of secondary primaries

    Time frame: 5 Y

  7. Endpoints of adjunct translational research program

    Time frame: 5 Y

Sponsors and collaborators

Lead sponsor

Ludwig-Maximilians - University of Munich

Other

Registry information

Official study title

Prospectively Randomized Phase III Trial, Studying the Benefits of Adjuvant Sequential vs. Combined Taxane Based Chemotherapy, Followed by Different Biological Treatment Strategies in Early, HER2-positive Breast Cancer

Important dates

Study start
2008
Primary completion
2011
First posted
May 2, 2008
Registry last updated
Apr 3, 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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