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A Randomized Phase II Study of Trastuzumab Emtansine (T-DM1) vs. Paclitaxel in Combination With Trastuzumab for Stage I HER2-Positive Breast Cancer (ATEMPT Trial)

Phase 2
18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

A Randomized Phase II Study of Trastuzumab Emtansine (T-DM1) vs. Paclitaxel in Combination With Trastuzumab for Stage I HER2-Positive Breast Cancer (ATEMPT Trial)

If a participant agrees to participate in this study she will be asked to undergo some
screening tests or procedures to confirm that she is eligible. Many of these tests and
procedures are likely to be part of regular cancer care and may be done even if turns out
that she does not take part in this research study. If she has had some of these tests or
procedures recently, they may or may not have to be repeated. These tests and procedures
will include: a medical history, performance status, assessment of your tumor, blood tests,
cardiac tests, pregnancy test and a collection of tumor tissue. If these tests show that she
is eligible to participate in the research study, she will begin the study treatment. If she
does not meet the eligibility criteria, she will not be able to participate in this research

Because no one knows which of the study options is best, the participant will be
"randomized" into one of the study groups after she has had her breast surgery: Group A or
Group B. Randomization means that she is put into a group by chance. Neither the participant
nor the research doctor will choose what group she will be in. The participant will have a
one in three chance of being placed in any group. Approximately 375 study participants will
receive the study drug, while 125 study participants will receive the standard therapy of
trastuzumab and paclitaxel.

Group A participants will receive the study drug T-DM1 every three weeks by IV (intravenous
injection) for a total of 17 weeks.

Group B participants will receive the FDA-approved drugs Paclitaxel and Trastuzumab once per
week by IV for 12 weeks. Then beginning week 13, participants will receive Trastuzumab only
by IV injection every three weeks for the next 13 weeks.

During all cycles the participant will have a physical exam and tumor assessment.

The investigators would like to keep track of the participant's medical condition for the
next five years after the final dose of study drug. The investigators would like to do this
by regular visits every 6 months for 3 years after completion of study treatment, and then
once a year for the next two years. The investigators may ask for additional follow-up by
phone after completion of these visits.

Participants who undergo lumpectomy (breast conserving surgery) need to receive breast
radiation therapy to participate in this study. Participants who have undergone a mastectomy
may receive chest wall and lymph node radiation (as determined by discussion with their
physician). Radiation Therapy will begin after the conclusion of all study paclitaxel doses,
and after 12 weeks fo the study drug T-DM1.

Inclusion Criteria:

- HER2-positive Stage I histologically confirmed invasive carcinoma of the breast

- ER/PR determination is required

- HER2 positive, confirmed by central testing: IHC 3+ or FISH HER2/CEP17 >/= 2

- Bilateral breast cancers that individually meet eligibility criteria are allowed

- Subjects with multifocal or multicentric disease are eligible as long as each tumor
individually meets eligibility criteria

- Should have tumor tissue available and a tissue block of sufficient size to make 15
slides, which must be sent to a DFCI site for testing

- Less than or equal to 90 days since most recent breast surgery for this breast cancer

- All tumor should be removed by either a modified radical mastectomy or a segmental
mastectomy (lumpectomy) with either a sentinel node biopsy or axillary dissection

- All margins should be clear of invasive cancer or DCIS

- May have received up to 4 weeks of tamoxifen therapy or other hormonal therapy, for
adjuvant therapy for this cancer

- Prior oophorectomy for cancer prevention is allowed

- Must have discontinued any investigational drug at least 2 weeks prior to

- Willing to use one highly effective from of nonhormonal contraception or two
effective forms of nonhormonal contraception while on study and for 6 months after
end of study treatment

- Subjects who have undergone partial breast radiation (duration registration are eligible

- Subjects with a history of ipsilateral DCIS are eligible if they were treated with
wide-excision alone, without radiation therapy

- Subjects undergoing lumpectomy must have no contraindications to radiation therapy

Exclusion Criteria:

- Pregnant or breastfeeding

- Use of potent CYP3A4 inhibitors during the study treatment period

- Excessive alcohol intake

- Locally advanced tumors at diagnosis

- History of previous invasive breast cancer

- History of prior chemotherapy in the past 5 years

- History of prior trastuzumab or prior paclitaxel therapy

- Active, unresolved infection

- Active liver disease

- History of a different malignancy except for the following: disease free for at least
5 years and at low risk for recurrence; cervical cancer in situ, basal or squamous
cell carcinoma of the skin

- Active cardiac disease

Type of Study:


Study Design:

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

Outcome Measure:

Disease Free Survival in Patients Treated with T-DM1

Outcome Description:

Disease-free survival (DFS) in patients with Stage I HER2-positive breast cancer treated with trastuzumab emtansine

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Sara Tolaney, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

May 2013

Completion Date:

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms



Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617
Dana-Farber Cancer Institute at Faulkner Hospital Boston, Massachusetts  02215
Dana-Farber Cancer Institute at Milford Hospital Milford, Massachusetts  01757
New Hampshire Oncology-Hematology, PA Concord, New Hampshire  03301
Dana-Farber Cancer Insitute at Londonderry Hospital Londonderry, New Hampshire  03053