Description:
This is a randomized phase II study to evaluate if the combination of T-DM1 with palbociclib
improves progression-free survival compared to single agent T-DM1in patients with metastatic
HER2 positive breast cancer
Title
- Brief Title: T-DM1 and Palbociclib for Metastatic HER2 Breast Cancer
- Official Title: A Randomized Phase II Study to Evaluate Efficacy of T-DM1 With or Without Palbociclib in the Treatment of Patients With Metastatic HER2 Positive Breast Cancer
Clinical Trial IDs
- ORG STUDY ID:
29747
- SECONDARY ID:
T-DM1
- SECONDARY ID:
Palbo T-DM1
- NCT ID:
NCT03530696
Conditions
- HER2-positive Breast Cancer
- Breast Cancer
- Breast Cancer Stage
- Recurrent Breast Cancer
- Metastatic Breast Cancer
- HER2 Positive Breast Carcinoma
Interventions
Drug | Synonyms | Arms |
---|
Palbociclib | Ibrance | T-DM1 with palbociclib |
T-DM1 | Kadcyla | T-DM1 |
Purpose
This is a randomized phase II study to evaluate if the combination of T-DM1 with palbociclib
improves progression-free survival compared to single agent T-DM1in patients with metastatic
HER2 positive breast cancer
Detailed Description
This is a multi-center, randomized, phase II study of T-DM1 with or without palbociclib in
the treatment of patients with metastatic HER2-positive breast cancer. Patients will be
randomized 1:1 to T-DM1 with or without palbociclib.
Hypotheses: Combination of T-DM1 with palbociclib improves progression free survival compared
to single agent T-DM1
Primary objective: Compare progression free survival of the combination arm (T-DM1 with
palbociclib) to single agent T-DM1
Secondary objectives i) Compare response rates between both treatment arms ii) Compare
overall survival between both treatment arms
Correlative objectives i) Investigate predictive biomarkers of response in blood and archived
tumor tissue ii) Investigate mechanisms of resistance for palbociclib in blood and tumor
tissue
Trial Arms
Name | Type | Description | Interventions |
---|
T-DM1 with palbociclib | Experimental | T-DM1 is given IV every 21 days Palbociclib is administered days 5-18 | |
T-DM1 | Active Comparator | T-DM1 is given IV every 21 days | |
Eligibility Criteria
Inclusion Criteria:
1. Be informed of the investigational nature of the study and all pertinent aspects of
the trial
2. Sign and provide written consent in accordance with institutional and federal
guidelines.
3. ECOG Performance status of 0-2
4. Recurrent or metastatic HER2-positive breast cancer (HER2 positive is defined per
ASCO-CAP guidelines)
5. Adequate cardiac reserve (EF≥50%)
6. Serum creatinine ≤ 1.5 x institutional upper limit of normal (IULN), bilirubin ≤ 2.0,
and an SGOT/SGPT/alkaline phosphatase ≤ 2.0 x IULN
7. Adequate bone marrow function (ANC ≥1000, Platelets ≥100,000/ml, Hemoglobin ≥10gm/dL)
8. Be willing and able to comply with scheduled visits, treatment plan, laboratory tests
and other trial procedures
9. Been treated with pertuzumab previously (neoadjuvant or metastatic setting). Patients
who weren't able to tolerate pertuzumab due to side effects can be eligible for study
upon discussion with the study PI
10. No more than 2 lines of therapy in the metastatic disease setting
Exclusion Criteria:
1. HER2 negative tumors
2. Prior treatment with T-DM1
3. Prior treatment with CDK 4/6 inhibitors
4. Known active CNS metastases or carcinomatous meningitis. Patients with stable CNS
metastases including brain metastases who have completed a course of radiotherapy are
eligible for the study provided they are clinically stable. However, oral
corticosteroids for control of CNS symptoms are not allowed on study
5. Known documented or suspected hypersensitivity to the components of the study drug(s)
or analogs.
6. Uncontrolled systemic illness, including but not limited to ongoing or active
infection
7. Symptomatic congestive heart failure, unstable angina pectoris, stroke or myocardial
infarction within 3 months
8. Be pregnant or breast feeding. Female subjects must be surgically sterile or be
postmenopausal, or must agree to use effective contraception during the period of
therapy. All female subjects with reproductive potential must have a negative
pregnancy test (serum or urine) prior to enrollment and must agree to use effective
contraception during the period of therapy
9. Concurrent hormonal or other anti-neoplastic therapy is not allowed. Patients can
receive supportive therapy like bone-directed therapy including bisphosphonates or
denosumab
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Compare progression-free survival |
Time Frame: | 4 years |
Safety Issue: | |
Description: | Compare progression-free survival of the combination arm (T-DM1 with palbociclib) to single agent T-DM1 |
Secondary Outcome Measures
Measure: | Compare response rates |
Time Frame: | 4 years |
Safety Issue: | |
Description: | Compare response rates between both treatment arms |
Measure: | Compare overall survival |
Time Frame: | 4 years |
Safety Issue: | |
Description: | Compare overall survival between both treatment arms |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | University of Arizona |
Trial Keywords
- Breast Cancer
- HER2-positive
- T-DM1
- HER2-positive Breast Cancer
- Recurrent Breast Cancer
- Metastatic Breast Cancer
Last Updated
September 3, 2020