NCT00670878

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

Completed Phase 3 Last updated 31 March 2012

What this trial tests

Phase 3 trial testing 3 x FEC 3 x DOC / Gemcitabine in Breast Cancer in 799 participants. Completed.

Timeline

1 June 2008

Primary endpoint
1 October 2011

Quick facts

Lead sponsor	Ludwig-Maximilians - University of Munich
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	none
Primary purpose	treatment
Enrollment	799
Start date	1 June 2008
Primary completion	1 October 2011
Sites	1 location across Germany

Drugs / interventions tested

• 3 x FEC 3 x DOC / Gemcitabine — full drug profile →
• 3 x FEC 3 x DOC — full drug profile →

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

Ludwig-Maximilians - University of Munich

Who can join

18 and older, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Disease free survival
  Time frame: 5 y

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. The HER2 phenotype of circulating tumor cells in HER2-positive early breast cancer: A translational research project of a prospective randomized phase III trial.
   Jaeger BAS, Neugebauer J, Andergassen U, Melcher C, et al · · 2017 · cited 43× · PMID 28586395 · DOI 10.1371/journal.pone.0173593
2. Meaningful prevention of breast cancer metastasis: candidate therapeutics, preclinical validation, and clinical trial concerns.
   Zimmer AS, Steeg PS. · · 2015 · cited 13× · PMID 25412774 · DOI 10.1007/s00109-014-1226-2
3. Effect of histological breast cancer subtypes invasive lobular versus non-special type on survival in early intermediate-to-high-risk breast carcinoma: results from the SUCCESS trials.
   Dayan D, Lukac S, Rack B, Ebner F, et al · · 2023 · cited 7× · PMID 38098086 · DOI 10.1186/s13058-023-01750-0
4. Age-dependent differences in survival of patients with early breast cancer: analysis of SUCCESS A, B, C trials.
   Lukac S, Dayan D, Janni W, Rack B, et al · · 2026 · PMID 41711956 · DOI 10.1007/s00404-025-08255-5