ATEMPT 2.0: Adjuvant T-DM1 vs TH
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDana-Farber Cancer Institute
About this trial
This research study is studying how well newly diagnosed breast cancer that has tested positive 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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients must have HER2-positive Stage I histologically confirmed invasive carcinoma of the breast. Patients must have node-negative (N0) or micrometastases (N1mic) breast cancer according to the AJCC 8th edition anatomic staging table.
If the patient has had a negative sentinel node biopsy, then no further axillary dissection is required, and the patient is determined to be node-negative. If an axillary dissection without sentinel lymph node biopsy is performed to determine nodal status, at least six axillary lymph nodes must be removed and analyzed, and determined 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 or immunohistochemistry (IHC) will be considered node-negative.
Any axillary lymph node with tumor clusters between 0.02 and 0.2 cm is considered a micrometastasis. Patients with a micrometastasis are eligible. An axillary dissection is not required to be performed in patients with a micrometastasis found by sentinel node evaluation. In cases where the specific pathologic size of lymph node involvement is subject to interpretation, the principal investigator will make the final determination as to eligibility. The investigator must document approval in the patient medical record.
Patients who have an area of a T1aN0, ER+ (defined as >10%), HER2-negative cancer in addition to their primary HER2-positive tumor are eligible.
Disqualifiers
Pregnant women
Nursing women
Women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragms, IUDs, surgical sterilization, abstinence, etc.).
Men who are unwilling to employ adequate contraception (condoms, surgical sterilization, abstinence, etc.).
Trial design
Design model
Parallel
Treatments tested in this trial
trastuzumab-emtansine
Drugintravenous infusion
Trastuzumab SC
DrugMuscular injection
Paclitaxel
Drugintravenous infusion
Treatment groups
500 Participants
are divided into 2 treatment groupsGroup A: Arm A. T-DM1 followed by Trastuzumab SCExperimental treatment 2 interventions
Group B: Arm B: Paclitaxel with Trastuzumab SC, followed by Trastuzumab SC aloneExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Incidence of clinically relevant toxicities (CRT)
Compare the incidence of clinically relevant toxicities (CRT) in patients with Stage I HER2-positive breast cancer treated with trastuzumab emtansine followed by trastuzumab SC to the incidence in those treated with paclitaxel in combination with trastuzumab SC as assessed by PRO-CTCAE
Time frame
First 18 weeks of treatment2
Disease Free Survival (DFS)
Evaluate disease-free survival in the T-DM1 followed by trastuzumab SC arm
Time frame
Time from randomization to first Disease Free Survival (DFS) event up to 72 monthsSecondary outcomes
1
Grade 3 and 4 adverse events
Compare the incidence of all grade 3 and 4 adverse events in patients treated with adjuvant trastuzumab emtansine followed by trastuzumab SC to the incidence in those receiving paclitaxel in combination with trastuzumab SC
Time frame
Enrollment to end of treatment up to 1 year2
Quality of Life Assessment: FACT B
Compare responses to FACT-B quality of life (QOL) questionnaire in patients receiving trastuzumab emtansine followed by trastuzumab SC to that experienced by patients receiving paclitaxel in combination with trastuzumab SC.
Time frame
Enrollment to end of treatment up to 1 year3
Symptoms related to therapy
Evaluate symptoms related to therapy in patients receiving trastuzumab emtansine followed by trastuzumab SC compared to those receiving paclitaxel in combination with trastuzumab SC using the Rotterdam Symptom Checklist (RSCL)
Time frame
Enrollment to end of treatment up to 1 year4
Symptoms related to therapy
Evaluate symptoms related to therapy in patients receiving trastuzumab emtansine followed by trastuzumab SC compared to those receiving paclitaxel in combination with trastuzumab SC using the Patient Neurotoxicity Questionnaire (PNQ)
Time frame
Enrollment to end of treatment up to 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Dana-Farber Cancer Institute
Lead sponsor
Genentech, Inc.
Collaborator
Source ClinicalTrials.gov