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

NCT02214381 | Completed Phase 3 DMC

• 1 other identifier: WSG-AM06 / ADAPT Elderly
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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

Keywords

breast cancer; elderly

Outcome Measures

Primary Outcomes (1)

• Comparison of pCR rates in patients with early response and no severe toxicity (Group 1) and in other patients (Group 2).

  After 5 years of follow-up.

Secondary Outcomes (4)

• Incidence of febrile neutropenia (FN) after 1 x MC in patients with primary prophylaxis (PP) vs. others.

  After 5 years of follow-up.

• Toxicity in the 4 x MC versus 2 x MC followed 6 x Pac arm as measured by adverse events.

  After 5 years of follow-up.

• Number of pCR in non-responders to MC.

  After 5 years of follow-up.

• G-CSF use in terms of primary or secondary prophylaxis per patient including occurence febrile neutropenia per patient per cycle

  After 5 years of follow-up.

Study Arms (2)

Mycet/Cyclophosphamid

ACTIVE COMPARATOR

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.

Drug: Myocet; Drug: Cyclophosphamide

Myocet/Cyclophosphamide/Paclitaxel

ACTIVE COMPARATOR

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.

Drug: Myocet; Drug: Cyclophosphamide; Drug: Paclitaxel

Interventions

Myocet DRUG

Also known as: Doxorubicin

Mycet/Cyclophosphamid; Myocet/Cyclophosphamide/Paclitaxel

Cyclophosphamide DRUG

Mycet/Cyclophosphamid; Myocet/Cyclophosphamide/Paclitaxel

Paclitaxel DRUG

Myocet/Cyclophosphamide/Paclitaxel

Eligibility Criteria

• Age: 70 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• West German Study Group: lead
• Teva Pharmaceuticals USA: collaborator

Study Sites (2)

Ev. Krankenhaus Bethesda Brustzentrum Niederrhein

Mönchengladbach, 41061, Germany

Location

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

Munich, 81337, Germany

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Doxorubicin; Cyclophosphamide; Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes

Study Officials

• Nadia Harbeck, Prof. Dr.

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

  PRINCIPAL INVESTIGATOR

• Ulrike Nitz, Prof. Dr.

  Ev. Krankenhaus Bethesda Brustzentrum Niederrhein, Mönchengladbach, Germany

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2014
• First Posted: August 12, 2014
• Study Start: July 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: January 15, 2025
• Last Updated: February 27, 2025

Record last verified: 2024-11

Locations

DE (2)