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A Randomized, Multicenter, Open-Label Phase III Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy for Patients With HER2-Positive Primary Breast Cancer Who Have Residual Tumor Present Pathologically in the Breast or Axillary Lymph Nodes Following Preoperative Therapy


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

Thank you

Trial Information

A Randomized, Multicenter, Open-Label Phase III Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy for Patients With HER2-Positive Primary Breast Cancer Who Have Residual Tumor Present Pathologically in the Breast or Axillary Lymph Nodes Following Preoperative Therapy


Inclusion Criteria:



- Adult patient, >/= 18 years of age

- HER2-positive breast cancer

- Histologically confirmed invasive breast carcinoma

- Clinical stage T1-4/N0-3/M0 at presentation (patients with T1a/bN0 tumors will not be
eligible)

- Completion of preoperative systemic treatment consisting of at least 6 cycles with a
total duration of at least 16 weeks, including at least 9 weeks of trastuzumab and at
least 9 weeks of taxane-based therapy

- Adequate excision: surgical removal of all clinically evident disease in the breast
and lymph nodes as specified in protocol

- Pathological evidence of residual invasive carcinoma in the breast or axillary lymph
nodes following completion of preoperative therapy

- An interval of no more than 12 weeks between the date of surgery and the date of
randomization

- Known hormone-receptor status

- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

- Adequate hematologic, renal and liver function

- Left ventricular ejection fraction (LVEF) >/= 50% at screening and no decrease in
LVEF by more than 15% absolute points from pre-chemotherapy

- Women of childbearing potential and men with partners of childbearing potential must
be willing to use effective contraception as defined by protocol for the duration of
study treatment and for at least 6 months after the last dose of study treatment

- Documentation of hepatitis B virus and hepatitis C virus serology is required

Exclusion Criteria:

- Stage IV (metastatic) breast cancer

- History of any prior (ipsi- or contralateral breast cancer except lobular carcinoma
in situ

- Evidence of clinically evident gross residual or recurrent disease following
preoperative therapy and surgery

- Progressive disease during preoperative therapy

- Treatment with any anti-cancer investigational drug within 28 days prior to
commencing study treatment

- History of other malignancy within the last 5 years except for appropriately treated
carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer,
or other non-breast malignancies with a similar outcome to those mentioned above

- Patients for whom radiotherapy would be recommended for breast cancer treatment but
for whom it is contraindicated because of medical reasons

- Current NCI CTCAE (Version 4.0) Grade >/= 2 peripheral neuropathy

- History of exposure to the following cumulative doses of anthracyclines:

Doxorubicin > 240 mg/m2 Epirubicin > 480 mg/m2 For other anthracyclines, exposure
equivalent to doxorubicin > 240 mg/m2

- Cardiopulmonary dysfunction as defined by protocol

- Prior treatment with trastuzumab emtansine

- Current severe, uncontrolled systemic disease

- Pregnant or lactating women

- Any known active liver disease, e.g. due to HBV, HCV, autoimmune hepatic disorders,
or sclerosing cholangitis

- Concurrent serious uncontrolled infections or known infection with HIV

- History of intolerance, including Grade 3 to 4 infusion reaction or hypersensitivity
to trastuzumab or murine proteins

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Invasive disease-free survival (IDFS): Time from randomization to ipsilateral invasive breast tumor recurrence, ipsilateral local-regional invasive breast cancer recurrence, distant recurrence, contralateral invasive breast cancer, or death of any cause

Outcome Time Frame:

up to 10 years

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

United States: Food and Drug Administration

Study ID:

BO27938

NCT ID:

NCT01772472

Start Date:

April 2013

Completion Date:

March 2023

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms
  • Neoplasm, Residual

Name

Location

Hinsdale, Illinois  60521
New Britain, Connecticut  06052
Alexandria, Minnesota  56308
Albany, Georgia  31701
Fountain Valley, California  92708
Miami, Florida  33176
Albany, New York  12208
Cleveland, Ohio  44195
Philadelphia, Pennsylvania  19104
Nashville, Tennessee  37203-1632
Austin, Texas  78705
Seattle, Washington  98195
Flint, Michigan  48532
Louisville, Kentucky  40207
McLean, Virginia  22101
Scarborough, Maine  04074
Hackensack, New Jersey  07601
Anchorage, Alaska  
Denver, Colorado  
Baltimore, Maryland  21287
Charlotte, North Carolina  
Eugene, Oregon  
Milwaukee, Wisconsin  
Charleston, South Carolina  
Washington, District of Columbia  
Las Vegas, Nevada  89109
Sioux Falls, South Dakota  
Bismarck, North Dakota  58501