Status:
ACTIVE_NOT_RECRUITING
T-DM1 vs Paclitaxel/Trastuzumab for Breast (ATEMPT Trial)
Lead Sponsor:
Dana-Farber Cancer Institute
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. "Investigati...
Detailed Description
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 b...
Eligibility Criteria
Inclusion
- HER2-positive Stage I histologically confirmed invasive carcinoma of the breast
- ER/PR determination is required
- HER2 positive, confirmed by central testing: IHC 3+, FISH HER2/CEP17 \<2.0 with an average HER2 copy number \>/=6.0, or FISH HER2/CEP17 \>/= 2.0
- 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
- Subjects with a history of ipsilateral DCIS are eligible if they were treated with wide-excision alone, without radiation therapy; Patients with a history of contralateral DCIS are not eligible.
- 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
- Subjects who have undergone partial breast radiation (duration \</= 7 days) prior to registration are eligible. Partial breast radiation must be completed prior to 2 weeks before starting protocol therapy.
- Must have discontinued any investigational drug at least 2 weeks prior to participation
- Willing to use one highly effective from of nonhormonal contraception or two effective forms of nonhormonal contraception while on study and for 7 months after end of study treatment
- Subjects undergoing lumpectomy must have no contraindications to radiation therapy
Exclusion
- Pregnant or breastfeeding
- Use of potent CYP3A4 inhibitors during the study treatment period
- Excessive alcohol intake (more than 3 alcoholic beverages per day)
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
512 Patients enrolled
Trial Details
Trial ID
NCT01853748
Start Date
May 1 2013
End Date
December 1 2025
Last Update
March 17 2025
Active Locations (85)
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1
University of Alabama Birmingham
Birmingham, Alabama, United States, 35249
2
University of California San Francisco
San Francisco, California, United States, 94115
3
Hartford Hospital
Hartford, Connecticut, United States, 06102
4
Midstate Medical Center
Meriden, Connecticut, United States, 06451