CompletedPhase 2

T-DM1 vs Paclitaxel/Trastuzumab for Breast (ATEMPT Trial)

United States512 participantsStarted 2013-05

Plain-language 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. "Investigational" means that the drug is still being studied and that research doctors are trying to find out more about it-such as the safest dose to use, the side effects it may cause, and if the drug is effective for treating different types of cancer. It also means that the FDA has not approved this drug for use patients undergoing adjuvant treatment for HER2+ breast cancer. Trastuzumab emtansine (T-DM1) is a drug that may stop cancer cells from growing. This drug has been used in other research studies and information from those other research studies suggests that this drug may help to prevent the recurrence of breast cancer in this research study. The use of T-DM1 in this research study is experimental, which means it is not approved by any regulatory authority for the adjuvant treatment of HER2-positive breast cancer. However, it FDA-approved for metastatic HER2-positive breast cancer. T-DM1 has caused cancer cells to die in laboratory studies. In preclinical studies, this drug has prevented or slowed the growth of breast cancer. The breast cancer treatments (paclitaxel and Trastuzumab) used in this study are considered part of standard-of-care regimens in early breast cancer. A standard treatment means that this is a treatment that would be accepted by the majority of the medical community as a suitable treatment for your type of breast cancer. In this research study, the investigators are looking to see if the study drug T-DM1 will have less side effects than traditional HER2-positive breast cancer treatment of trastuzumab and paclitaxel. The investigators are also hoping to learn about the long term benefits and disease-free survival of participants who take the study drug T-DM1 in comparison to those participants to take the combination of trastuzumab and paclitaxel.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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+, 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 star…

What they're measuring

Number of Participants of Clinically Relevant Toxicities (CRT)

Timeframe: 5 years after completion of study treatment or until death, whichever occurs first.

3-year Disease Free Survival (DFS) Rate of Trastuzumab Emtansine (TDM-1)

Timeframe: 3 years

Trial details

NCT IDNCT01853748

SponsorDana-Farber Cancer Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-08-26

Results submitted2021-07-21