A Prospective, Multicenter, Open-label 12 Week Neoadjuvant Phase II Trial Optimizing Taxane Therapy in Elderly Patients With Low Response

NCT ID: NCT02214381

Last Updated: 2025-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2025-01-15

Brief Summary

Comparison of pre-surgical Myocet/ Cyclophosphamide (MC) q3w followed by either MC or Paclitaxel - depending on early response assessment by ultrasound or by toxicity for elderly non frail primary breast cancer patients with increased risk of relapse.

Conditions

Early Primary Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mycet/Cyclophosphamid

4 x Myocet 60 mg/m² q3w in combination with 4 x cyclophosphamide 600 mg/m² q3w depending on early response assessment by ultrasound or on toxicity profile.

Group Type: ACTIVE_COMPARATOR

Myocet

Intervention Type: DRUG

Cyclophosphamide

Intervention Type: DRUG

Myocet/Cyclophosphamide/Paclitaxel

2 x Myocet 60 mg/m² q3w in combination with 2 x cyclophosphamide 600 mg/m² q3w followed by 6 x paclitaxel 80 mg/m² q1w depending on early response assessment by ultrasound or on toxicity profile.

Group Type: ACTIVE_COMPARATOR

Myocet

Intervention Type: DRUG

Cyclophosphamide

Intervention Type: DRUG

Paclitaxel

Intervention Type: DRUG

Interventions

Myocet

Intervention Type: DRUG

Cyclophosphamide

Intervention Type: DRUG

Paclitaxel

Intervention Type: DRUG

Other Intervention Names

Doxorubicin

Eligibility Criteria

Inclusion Criteria

• Female patients, age at diagnosis 18 years and above (consider patients at 70 years and above for ADAPT Elderly)
• Candidate for chemotherapy on the basis of conventional criteria
• Histologically confirmed unilateral primary invasive carcinoma of the breast
• Clinical T1 - T4a-c
• All clinical N (cN)
• No clinical evidence for distant metastasis (M0)
• Known HR status and HER2 status (local pathology)
• Tumor block available for central pathology review
• Performance Status ECOG <= 1 or KI >= 80%
• Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requirements
• The patient must be accessible for treatment and follow-up
• Patients must qualify for neoadjuvant treatment
• LVEF > 50%; LVEF within normal limits of each institution measured by echocardiography and normal ECG (within 42 days prior to chemotherapy)

• Laboratory requirements :

• Leucocytes ≥ 3.5 x 109/L
• Platelets ≥ 100 x 109/L
• Hemoglobin ≥ 10 g/dL
• Total bilirubin ≤ 1 x ULN
• ASAT (SGOT) and ALAT (SGPT) ≤ 2.5 x UNL
• Creatinine ≤ 175 µmol/L (2 mg/dl)

• ≥ 70 years old
• Charlson scale ≤ 2
• HR+/HER2- disease: if RS and sequential testing are available N0-1/RS 12-25/poor response or N0-1/RS ≥26
• All G3 with Ki-67 ≥40% in tumors >1cm
• All N2
• All TN
• All subtypes

Exclusion Criteria

• Known hypersensitivity reaction to the compounds or incorporated substances
• Prior malignancy with a disease-free survival of < 10 years, except curatively treated basalioma of the skin, pTis of the cervix uteri
• Non-operable breast cancer including inflammatory breast cancer
• Previous or concurrent treatment with cytotoxic agents for any reason after consultation with the sponsor
• Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry (concurrent participation in non-interventional post authorization safety studies not influencing the primary study endpoints is allowed, e.g. WSG PROTROCA for evaluation of primary/secondary G-CSF prophylaxis)
• Male breast cancer
• Sequential breast cancer
• Reasons indicating risk of poor compliance
• Patient not able to consent

• Known polyneuropathy ≥ grade 2
• Severe and relevant co-morbidity that would interact with the application of cytotoxic agents or the participation in the study
• Inadequate organ function (e.g. hepatic impairment, pulmonary disease, etc.)
• Uncompensated cardiac function (current unstable ventricular arrhythmia requiring treatment, history of symptomatic CHF NYHA classes II-IV), history of myocardial infarction or unstable angina pectoris within 12 months of enrollment, history of severe hypertension, CAD - coronary artery disease)
• Severe dyspnea
• Pneumonitis
• Abnormal blood values:
• Thrombocytopenia > CTCAE grade 1
• Increases in ALT/AST > CTCAE grade 1
• Hypokalaemia > CTCAE grade 1
• Neutropenia > CTCAE grade 1
• Anaemia > CTCAE grade 1

• Minimum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Teva Pharmaceuticals USA

INDUSTRY

Sponsor Role: collaborator

West German Study Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nadia Harbeck, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Breast Center of the University of Munich (LMU) Universitätsfrauenklinik Großhadern, Munich, Germany

Ulrike Nitz, Prof. Dr.

Role: STUDY_CHAIR

Ev. Krankenhaus Bethesda Brustzentrum Niederrhein, Mönchengladbach, Germany

Locations

Ev. Krankenhaus Bethesda Brustzentrum Niederrhein

Mönchengladbach, , Germany

Breast Center of the University of Munich (LMU) Universitätsfrauenklinik Großhadern

Munich, , Germany

Countries

Germany

Other Identifiers

WSG-AM06 / ADAPT Elderly

Identifier Type: -

Identifier Source: org_study_id