ATEMPT 2.0: Adjuvant T-DM1 vs TH
K
Kathy Miller, MD
Primary Investigator
Enrolling By Invitation
18 years and older
All
Phase
2
500 participants needed
3 Locations
Overview
This research study is studying how well newly diagnosed breast cancer that has testedve for a protein called HER2 responds using one of two different combination of
HER2-directed therapies as a treatment after surgery.
The name of the study drugs involved are:
- Trastuzumab-emtansine (T-DM1, Kadcyla)
- Trastuzumab SC (Herceptin Hylecta)
- Paclitaxel
Description
This is a randomized phase II adjuvant study for women and men with Stage I HER2-positivevasive breast cancer. Participants will be randomized into one of two treatment arms inhis study and receive:
- Arm 1: trastuzumab-emtansine (T-DM1, Kadcyla) and trastuzumab SC (Herceptin Hylecta)
- Arm 2: paclitaxel and trastuzumab SC (Herceptin Hylecta) This research study is lookinghe study drug T-DM1 followed by trastuzumab SC will have less side-effectshan traditional HER2-positive breast cancer treatment of trastuzumab and paclitaxel.Theudy is also looking to learn about the long-term benefits and disease-free survival ofwho are treated with T-DM1 followed by trastuzumab SC.
T-DM1 is an antibody-drug conjugate; it is made up of an antibody (trastuzumab) linked to aytotoxic drug, DM1 (chemotherapy). T-DM1 functions as a targeted cancer therapy because itgets HER2-positive breast cancer cells directly, limiting exposure of the rest of the bodyhemotherapy. More specifically, the trastuzumab in T-DM1 first binds to the HER2 proteinhe surface of the breast cancer cells and the DM1 then enters the cells and can causehem to die, preventing tumor growth. The FDA (the U.S. Food and Drug Administration) has notved T-DM1 for use on its own in patients with stage I, II, or III breast cancer.
However, it has been approved for use in (a) advanced or metastatic, previously treated
breast cancer and (b) in some patients receiving postoperative treatment after preoperativehemotherapy and surgery have been completed.
Trastuzumab SC is a subcutaneous form of trastuzumab.Trastuzumab is a monoclonal antibody,
which are disease-fighting proteins made by cloned immune cells. Paclitaxel and trastuzumabdered a standard-of-care regimen in early breast cancer. Trastuzumab is FDA-approvedbe administered as an IV (intravenous) or subcutaneous (muscular injection).
The research study procedures include screening for eligibility and study treatment includingboratory evaluations and follow up visits.
Participants will receive study treatment for a year in total and will be followed for 5
years after treatment.
It is expected that about 500 people will take part in this research study.
Genentech is supporting this research study by providing funding for the study and supplyinguzumab-emtansine (T-DM1) and trastuzumab SC (subcutaneous).
Eligibility
You may be eligible for this study if you meet the following criteria:
-
Conditions:
Breast Cancer, HER2-positive Breast Cancer
-
Age: 18 Years
-
Gender: All
Inclusion Criteria:
- Patients must have HER2-positive Stage I histologically confirmed invasive carcinomahe breast. Patients must have node-negative (N0) or micrometastases (N1mic) breastding to the AJCC 8th edition anatomic staging table.
- If the patient has had a negative sentinel node biopsy, then no further axillarydissection is required, and the patient is determined to be node-negative. If any dissection without sentinel lymph node biopsy is performed to determinedal status, at least six axillary lymph nodes must be removed and analyzed, anddetermined to be negative, for the patient to be considered node-negative.Axillary nodes with single cells or tumor clusters ≤ 0.2 mm by either H&E orunohistochemistry (IHC) will be considered node-negative.
- Any axillary lymph node with tumor clusters between 0.02 and 0.2 cm is considered. Patients with a micrometastasis are eligible. An axillarydissection is not required to be performed in patients with a micrometastasisund by sentinel node evaluation. In cases where the specific pathologic size ofymph node involvement is subject to interpretation, the principal investigatorwill make the final determination as to eligibility. The investigator mustdocument approval in the patient medical record.
- Patients who have an area of a T1aN0, ER+ (defined as >10%), HER2-negative cancerddition to their primary HER2-positive tumor are eligible.
- HER2-positive: defined as 3+ by immunohistochemistry. FISH results will not be
considered for eligibility.
Updated on
15 May 2024.
Study ID: 21-159, CTO-21-159, 14246
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