ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
520-694-9079
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
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
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Descriptive Information | |||||||
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Brief Title ICMJE | T-DM1 and Palbociclib for Metastatic HER2 Breast Cancer | ||||||
Official Title ICMJE | 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 | ||||||
Brief Summary | 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 | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 2 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||||
Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Recruiting | ||||||
Estimated Enrollment ICMJE | 132 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | August 1, 2022 | ||||||
Estimated Primary Completion Date | August 21, 2021 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03530696 | ||||||
Other Study ID Numbers ICMJE | 29747 T-DM1 ( Other Identifier: The University of Arizona Cancer Center ) Palbo T-DM1 ( Other Identifier: The University of Arizona Cancer Center ) | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||||
Responsible Party | University of Arizona | ||||||
Study Sponsor ICMJE | University of Arizona | ||||||
Collaborators ICMJE | Pfizer | ||||||
Investigators ICMJE |
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PRS Account | University of Arizona | ||||||
Verification Date | September 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |