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A Multicenter, Single Arm 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.


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer

Thank you

Trial Information

A Multicenter, Single Arm 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.


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

Exclusion Criteria:

- History of treatment with trastuzumab emtansine

- Prior enrollment into a clinical study containing trastuzumab emtansine regardless of
having received trastuzumab emtansine or not

- Peripheral neuropathy of Grade >/= 3 per NCI CTCAE Version 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, or cancers
with a similar curative outcome as those mentioned above

- 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 study treatment.

- CNS only disease

- Brain metastases which are symptomatic

- History of a decrease in LVEF to < 40% or symptomatic CHF with previous trastuzumab
treatment

- History of symptomatic congestive heart failure (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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety: incidence of adverse events

Outcome Time Frame:

Up to approximately 5 years

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

France: Agence nationale de securité du médicament et des produits de santé (ANSM)

Study ID:

MO28231

NCT ID:

NCT01702571

Start Date:

November 2012

Completion Date:

March 2017

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

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