Neoadjuvant Chemotherapy With Myocet/Taxotere/Herceptin for HER2 Positive Breast Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00129896
Recruitment Status : Completed
First Posted : August 12, 2005
Last Update Posted : March 14, 2018
Zeneus Pharma
Hoffmann-La Roche
Information provided by (Responsible Party):
Spanish Breast Cancer Research Group

Brief Summary:

This is an open-label study to assess the efficacy and tolerability of the combination Myocet®/Taxotere®/Herceptin® as primary treatment for HER2 positive breast cancer patients. HER2 status will be confirmed centrally by fluorescence in situ hybridization (FISH).

Phase I: Initial doses will be:

Myocet: 50-60 mg/m² day 1 every 3 weeks; Taxotere 60-75 mg/m² day 1 every 3 weeks; and Herceptin (4) 2 mg/kg weekly.

Sample size will depend on the number of patients recruited during dose escalation. Three patients must be recruited in each dose level. If one out of three experiences a dose-limiting toxicity (DLT), 3 more patients must be recruited in the same dose level. Considering that there are 4 dose levels to be tested, the estimated number of patients is 9 to 24. Patients receiving the recommended dose (RD) will be incorporated into phase II of the study.

Phase II: The average pathological complete response rate reported in other trials is around 11%. The investigators expect to achieve an increase of 14% on this rate; that is, they expect a pathological response rate of 25%. With a= 0.05 and β=0.2, 18 patients are initially needed. If at least 3 pathological complete responses are achieved, recruitment will continue to up to 53 patients. At least 10 pathological complete responses are needed to probe the hypothesis. Considering a 10% post-randomization drop-out rate, a total of 59 patients must be recruited for the trial.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Myocet Drug: Taxotere Drug: Herceptin Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label Phase I-II Clinical Trial to Evaluate Treatment With Myocet/Taxotere/Herceptin as Primary Chemotherapy Treatment for HER2neu Positive Breast Cancer Patients
Actual Study Start Date : January 2004
Actual Primary Completion Date : December 2008
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Docetaxel

Arm Intervention/treatment
Experimental: Myocet+Taxotere+Herceptin
Myocet 50 mg/m2; Taxotere 60 mg/m2; Herceptín 4 mg/Kg (first dose) and in the following cycles 2 mg/Kg
Drug: Myocet
Myocet®: 60-75 mg/m² ASC (vía IV) día 1 / c3s for 6 cycles
Other Name: Lyposomal Doxorubicin

Drug: Taxotere
Taxotere® 70-75 mg/m² ASC (vía IV) día 1 / c3s for 6 cycles
Other Name: Docetaxel

Drug: Herceptin
Herceptin® (4) 2 mg/kg (vía IV) Semanal for 6 cycles
Other Name: Trastuzumab

Primary Outcome Measures :
  1. Efficacy and tolerability of Myocet/Taxotere/Herceptin

Secondary Outcome Measures :
  1. Tumour response (clinical and radiological response)
  2. Surgery (conservative surgery versus mastectomy)
  3. Potential cardiac toxicity (left ventricular ejection fraction [LVEF] by multiple-gated acquisition [MUGA])
  4. Overall tolerability
  5. Post-surgery node status
  6. Disease-free survival
  7. Molecular changes in blood and tissue exams

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Written informed consent.
  • Breast cancer stages II and IIIA with histological diagnoses by true-cut.
  • Breast cancer tumours overexpressing HER2neu, centrally confirmed by FISH.
  • No evidence of metastasis: bilateral mammography, thorax x-ray, computed tomography (CT)-scan or abdominal echography and bone scintigraphy.
  • Estrogen and progesterone hormone receptor status, determined before study registration.
  • Age >= 18 years old.
  • Performance status (Karnofsky index) >= 80.
  • Adequate cardiac function by LVEF in the previous 14 days.
  • Hematology: neutrophils >= 2.0 x10^9/l; platelets >= 100 x10^9/l; hemoglobin >= 10 g/dl.
  • Adequate hepatic function: total bilirubin <= 1x upper normal limit (UNL); SGOT and SGPT <= 2.5xUNL; alkaline phosphatase <= 2.5xUNL.
  • Adequate renal function: creatinine <= 1xUNL; creatinine clearance >= 60 ml/min.
  • Patients able to comply with study treatment and follow-up.
  • Negative pregnancy test in the previous 14 days.
  • Adequate contraceptive method during the study and up to 3 months after definitive surgery.

Exclusion Criteria:

  • HER2neu negative tumours.
  • Prior systemic therapy for breast cancer.
  • Prior treatment with anthracyclines or taxanes (paclitaxel, docetaxel) for any previous malignancy.
  • Prior radiotherapy for breast cancer.
  • Bilateral invasive breast cancer.
  • Pregnant or lactating women.
  • Previous grade >= 2 motor or sensorial neurotoxicity (National Cancer Institute Common Toxicity Criteria [NCI CTC]).
  • Other serious comorbidities: congestive heart failure or unstable angina; prior history of myocardial infarction in previous year; uncontrolled hypertension (HT); high risk arrhythmias; history of significant neurological or psychiatric disorders; uncontrolled active infection; active peptic ulcer; unstable diabetes mellitus; dyspnea at rest; or chronic therapy with oxygen.
  • Previous or current history of neoplasms different from breast cancer, except for skin carcinoma, cervical in situ carcinoma, or any other tumor curatively treated and without recurrence in the last 10 years; ductal in situ carcinoma in the same breast; lobular in situ carcinoma.
  • Chronic treatment with corticosteroids.
  • Contraindications for administration of corticosteroids, anthracyclines, docetaxel, trastuzumab or egg derivates.
  • Concomitant treatment with other therapy for cancer.
  • Males.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00129896

Hospital Universitario Virgen de los Lirios
Alcoy, Alicante, Spain, 03804
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Althaia-Xarxa Assistencial de Manresa
Manresa, Barcelona, Spain, 08243
Corporació Sanitaria Parc Taulí
Sabadell, Barcelona, Spain, 08208
Consorci Sanitari de Terrassa
Terrassa, Barcelona, Spain, 08227
Donostia-San Sebastian, Guipúzcoa, Spain, 20012
Hospital de la Ribera
Alzira, Valencia, Spain, 46600
Complejo Hospitalario Universitario A Coruña
A Coruña, Spain, 15006
Hospital Infanta Cristina
Badajoz, Spain, 06080
Hospital Clinic i Provincial
Barcelona, Spain, 08036
Complejo Hospitalario de Jaén
Jaén, Spain, 23007
Hospital Universitario Lucus Augusti
Lugo, Spain, 27004
Hospital Clínico Universitario Virgen de la Victoria
Málaga, Spain, 29010
Instituto Valenciano de Oncología
Valencia, Spain, 46009
Hospital Universitario La Fe
Valencia, Spain, 46026
Hospital Universitario Miguel Servet
Zaragoza, Spain, 50009
Sponsors and Collaborators
Spanish Breast Cancer Research Group
Zeneus Pharma
Hoffmann-La Roche
Study Director: Study Director Hospital Univesitario Miguel Servet

Additional Information:
Responsible Party: Spanish Breast Cancer Research Group Identifier: NCT00129896     History of Changes
Other Study ID Numbers: GEICAM 2003-03
First Posted: August 12, 2005    Key Record Dates
Last Update Posted: March 14, 2018
Last Verified: February 2018

Keywords provided by Spanish Breast Cancer Research Group:
Her2neu positive breast cancer.
Neoadjuvant treatment.

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors