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

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ClinicalTrials.gov Identifier: NCT02214381
Recruitment Status : Recruiting
First Posted : August 12, 2014
Last Update Posted : June 19, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Early Primary Breast Cancer in the Elderly. Drug: Myocet Drug: Cyclophosphamide Drug: Paclitaxel Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, Open-label 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.
Study Start Date : July 2014
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: 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.
Drug: Myocet
Other Name: Doxorubicin
Drug: Cyclophosphamide
Active Comparator: 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.
Drug: Myocet
Other Name: Doxorubicin
Drug: Cyclophosphamide Drug: Paclitaxel


Outcome Measures

Primary Outcome Measures :
  1. Comparison of pCR rates in patients with early response and no severe toxicity (Group 1) and in other patients (Group 2). [ Time Frame: After 5 years of follow-up. ]

Secondary Outcome Measures :
  1. Incidence of febrile neutropenia (FN) after 1 x MC in patients with primary prophylaxis (PP) vs. others. [ Time Frame: After 5 years of follow-up. ]
  2. Toxicity in the 4 x MC versus 2 x MC followed 6 x Pac arm as measured by adverse events. [ Time Frame: After 5 years of follow-up. ]
  3. Number of pCR in non-responders to MC. [ Time Frame: After 5 years of follow-up. ]
  4. G-CSF use in terms of primary or secondary prophylaxis per patient including occurence febrile neutropenia per patient per cycle [ Time Frame: After 5 years of follow-up. ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

General Inclusion Criteria for ADAPT:

  • 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)

Additional inclusion criteria ADAPT Elderly:

  • ≥ 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

General Exclusion Criteria for ADAPT:

  • 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

Additional Exclusion Criteria ADAPT Elderly:

  • 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
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT02214381


Contacts
Contact: Daniel Hofmann, Dr. rer. medic. +49 2161 566 23 ext 17 daniel.hofmann@wsg-online.com
Contact: Study Center +49 2161 566 23 ext 10 wsg@wsg-online.com

Locations
Germany
Ev. Krankenhaus Bethesda Brustzentrum Niederrhein Recruiting
Moenchengladbach, Germany, 41061
Contact: Ulrike Nitz, Prof. Dr.    +4921619812330    ulrike.nitz@wsg-online.com   
Principal Investigator: Raquel von Schumann, MD         
Breast Center of the University of Munich (LMU) Universitätsfrauenklinik Großhadern Recruiting
Munich, Germany, 81337
Contact: Nadia Harbeck, Prof. Dr.         
Principal Investigator: Nadia Harbeck, Prof. Dr.         
Sponsors and Collaborators
West German Study Group
TEVA
Investigators
Principal Investigator: Nadia Harbeck, Prof. Dr. Breast Center of the University of Munich (LMU) Universitätsfrauenklinik Großhadern, Munich, Germany
Study Chair: Ulrike Nitz, Prof. Dr. Ev. Krankenhaus Bethesda Brustzentrum Niederrhein, Mönchengladbach, Germany
More Information

Responsible Party: West German Study Group
ClinicalTrials.gov Identifier: NCT02214381     History of Changes
Other Study ID Numbers: WSG-AM06 / ADAPT Elderly
First Posted: August 12, 2014    Key Record Dates
Last Update Posted: June 19, 2015
Last Verified: June 2015

Keywords provided by West German Study Group:
breast cancer
elderly

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Cyclophosphamide
Doxorubicin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors