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

Purpose

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.

Condition	Intervention	Phase
Breast Cancer	Drug: 3 x FEC 3 x DOC / Gemcitabine Drug: 3 x FEC 3 x DOC	Phase III

Genetics Home Reference related topics:

breast cancer

MedlinePlus related topics:

Breast Cancer Cancer

ChemIDplus related topics:

Cyclophosphamide Docetaxel Gemcitabine hydrochloride Gemcitabine Fluorouracil Epirubicin hydrochloride Epirubicin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Factorial Assignment

Official 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

Further study details as provided by Ludwig-Maximilians - University of Munich:

Primary Outcome Measures:

Disease free survival [ Time Frame: 5 y ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall survival time after randomization [ Time Frame: 5 Y ] [ Designated as safety issue: No ]
Distant disease free survival [ Time Frame: 5 Y ] [ Designated as safety issue: No ]
Toxicity [ Time Frame: 5 Y ] [ Designated as safety issue: No ]
Changes in quality of life over time as defined by EORTC QLQ-C30 and QLQBR23 questionnaire [ Time Frame: 5 Y ] [ Designated as safety issue: No ]
Skeletal related events [ Time Frame: 5 Y ] [ Designated as safety issue: No ]
Incidence of secondary primaries [ Time Frame: 5 Y ] [ Designated as safety issue: No ]
Endpoints of adjunct translational research program [ Time Frame: 5 Y ] [ Designated as safety issue: No ]

Estimated Enrollment:	799
Study Start Date:	June 2008
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: 3 x FEC 3 x DOC / Gemcitabine 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
B: Active Comparator	Drug: 3 x FEC 3 x DOC 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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00670878

Contacts


Contact: Harald Sommer, Professor	49-89-5160 ext 4170	harald.sommer@med.uni-muenchen.de

Contact: Philip Hepp, Doktor	49-89-5160 ext 4170	philip.hepp@med.uni-muenchen.de

Locations


Germany
	Frauenklinik der Universität München Campus Innenstadt	Recruiting
	Munich, Germany, 80337

Sponsors and Collaborators

Ludwig-Maximilians - University of Munich

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Ludwig-Maximilians - University of Munich ( Prof. Harald Sommer )
Study ID Numbers:	SUCCESS-B
First Received:	April 30, 2008
Last Updated:	August 5, 2008
ClinicalTrials.gov Identifier:	NCT00670878
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; Germany: Ethics Commission

Study placed in the following topic categories:

Docetaxel

Skin Diseases

Fluorouracil

Breast Neoplasms

Cyclophosphamide

Gemcitabine

Taxane

Epirubicin

Breast Diseases

Additional relevant MeSH terms:

Antimetabolites

Anti-Infective Agents

Antimetabolites, Antineoplastic

Molecular Mechanisms of Pharmacological Action

Immunologic Factors

Antineoplastic Agents

Physiological Effects of Drugs

Enzyme Inhibitors

Antiviral Agents

Immunosuppressive Agents

Pharmacologic Actions

Neoplasms

Neoplasms by Site

Radiation-Sensitizing Agents

Therapeutic Uses

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	Ludwig-Maximilians - University of Munich
Information provided by:	Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:	NCT00670878