A Study of Kadcyla (Trastuzumab Emtansine) in Patients With HER2 Positive Breast Cancer Who Have Received Prior Anti-HER2 And Chemotherapy-based Treatment

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01702571
First received: October 4, 2012
Last updated: August 26, 2014
Last verified: August 2014
  Purpose

This two-cohort, open-label, multicenter study will assess the safety and the ef ficacy of Kadcyla in patients with HER2-positive locally advanced or metastatic breast cancer who have received prior anti-HER2 and chemotherapy-based treatment Patients in Cohort 1 will be drawn from the general patient population; Cohort 2 will include only asian patients. Patients in both cohorts will receive 3.6 m g/kg Kadcyla intravenously every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.


Condition Intervention Phase
Breast Cancer
Drug: Kadcyla (trastuzumab emtansine)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Two-cohort, Open-label, Multicenter Study of Trastuzumab Emtansine (T-DM1) in HER2-positive Locally Advanced or Metastatic Breast Cancer Patients Who Have Received Prior Anti-HER2 and Chemotherapy-based Treatment.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Safety: incidence of adverse events [ Time Frame: Up to approximately 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival according to response evaluation for solid tumors (RECIST) v.1.1 [ Time Frame: Up to approximately 4 years ] [ Designated as safety issue: No ]
  • Overall survival according to RECIST v.1.1 [ Time Frame: Up to approximately 4 years ] [ Designated as safety issue: No ]
  • Overall response rate according to RECIST v.1.1 [ Time Frame: Up to approximately 4 years ] [ Designated as safety issue: No ]
  • Clinical benefit rate according to RECIST v.1.1 [ Time Frame: Up to approximately 4 years ] [ Designated as safety issue: No ]
  • Duration of response according to RECIST v.1.1 [ Time Frame: Up to approximately 4 years ] [ Designated as safety issue: No ]
  • Time to response according to RECIST v.1.1 [ Time Frame: Up to approximately 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 2220
Study Start Date: November 2012
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1 Drug: Kadcyla (trastuzumab emtansine)
3.6 mg/kg intravenously every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression
Experimental: Cohort 2 Drug: Kadcyla (trastuzumab emtansine)
3.6 mg/kg intravenously every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HER2-positive disease determined locally
  • Histologically or cytologically confirmed invasive breast cancer
  • Prior treatment for breast cancer in the adjuvant, unresectable, locally advanced or metastatic setting must include both chemotherapy, alone or in combination with another agent, and an anti-HER2 agent, alone or in combination with another agent
  • Documented progression of incurable, unresectable, locally advanced, or metastatic breast cancer (mBC), defined by the investigator: progression must occur during or after most recent treatment for locally advanced/mBC or within 6 months of completing adjuvant therapy
  • Measurable and/or non-measurable disease
  • Left ventricular ejection fraction (LVEF) >/=50% by either echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2
  • Adequate organ function
  • Use of highly effective contraception as defined by the protocol
  • Cohort 2: only Asian patients will be enrolled

Exclusion Criteria:

  • History of treatment with Kadcyla
  • Prior enrollment into a clinical study containing Kadcyla regardless of having received Kadcyla or not
  • Peripheral neuropathy of Grade >/= 3 per National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) v. 4.0
  • History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage 1 uterine cancer, synchronous or previously diagnosed HER2-positive breast cancer
  • History of receiving any anti-cancer drug/biologic or investigational treatment within 21 days prior to first study treatment except hormone therapy, which can be given up to 7 days prior to first study treatment; recovery of treatment-related toxicity consistent with other eligibility criteria
  • History of exposure to cumulative doses of anthracyclines
  • History of radiation therapy within 14 days of first study treatment. The patient must have recovered from any resulting acute toxicity (to Grade </=1) prior to first study treatment.
  • Central nervous system (CNS)-only disease
  • Brain metastases which are symptomatic
  • History of a decrease in LVEF to < 40% or symptomatic congestive heart failure (CHF) with previous trastuzumab treatment
  • History of symptomatic CHF (New York Heart Association [NYHA] Classes II-IV) or serious cardiac arrhythmia requiring treatment
  • History of myocardial infarction or unstable angina within 6 months of first study treatment
  • Current dyspnea at rest due to complications of advanced malignancy or requirement for continuous oxygen therapy
  • Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease)
  • Currently known active infection with HIV, hepatitis B virus, or hepatitis C virus
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01702571

Contacts
Contact: Reference Study ID Number: MO28231 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Show 288 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01702571     History of Changes
Other Study ID Numbers: MO28231, 2012-001628-37
Study First Received: October 4, 2012
Last Updated: August 26, 2014
Health Authority: France: Agence nationale de securité du médicament et des produits de santé (ANSM)

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Ado-trastuzumab emtansine
Maytansine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on September 18, 2014