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CDK4/6 Inhibitor

T-DM1 for Breast Cancer (T-DM1 Trial)

Phase 2
Waitlist Available
Led By Pavani Chalasani, MD
Research Sponsored by University of Arizona
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights

T-DM1 Trial Summary

This trial will test if adding the drug palbociclib to the standard treatment of T-DM1 can help improve outcomes for people with metastatic HER2 positive breast cancer.

Eligible Conditions
  • Breast Cancer

T-DM1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Estimate progression-free survival
Secondary outcome measures
Estimate overall survival survival
Estimate response rates

Side effects data

From 2019 Phase 2 trial • 32 Patients • NCT02073487
69%
Liver Function Abnormality
50%
Fatigue
44%
Diarrhea
38%
Hypokalemia
19%
Neuropathy
19%
Rash
19%
Nausea
6%
Breast pain
6%
Musculoskeletal pain
6%
Hypomagnesemia
6%
Mucositis
6%
Depression
6%
Anxiety
6%
Chest pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab + Pertuzumab + Paclitaxel
T-DM1 + Lapatinib + Abraxane

T-DM1 Trial Design

1Treatment groups
Experimental Treatment
Group I: T-DM1 with palbociclibExperimental Treatment2 Interventions
T-DM1 is given intravenously every 21 days (day 1 of each cycle) Palbociclib is administered orally on days 5-18 of each cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
T-DM1
2014
Completed Phase 2
~450
Palbociclib
2017
Completed Phase 3
~3760

Find a Location

Who is running the clinical trial?

PfizerIndustry Sponsor
4,567 Previous Clinical Trials
10,911,820 Total Patients Enrolled
110 Trials studying Breast Cancer
36,350 Patients Enrolled for Breast Cancer
University of ArizonaLead Sponsor
514 Previous Clinical Trials
148,217 Total Patients Enrolled
22 Trials studying Breast Cancer
2,510 Patients Enrolled for Breast Cancer
Pavani Chalasani, MDPrincipal InvestigatorThe University of Arizona Cancer Center
7 Previous Clinical Trials
884 Total Patients Enrolled
4 Trials studying Breast Cancer
742 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has this type of research been conducted before?

"T-DM1 has undergone 176 clinical trials since the first one in 2008. These trials have taken place in 1767 cities across 68 countries and 110 of them have completed their Phase 2 drug approval stage."

Answered by AI

Does T-DM1 carry any risks for those who take it?

"T-DM1 was given a score of 2 out of 3 by our team because, while there is data supporting its safety, Phase 2 trials have not yet yielded evidence of efficacy."

Answered by AI

Could you please tell me how many individuals are included in this research project?

"As of February 15th, 2022, this trial is no longer recruiting patients. This particular study was originally posted on December 6th, 2018. If you are looking for similar studies, there are presently 2716 trials actively looking for participants with breast cancer and 176 trials for T-DM1 admitting patients."

Answered by AI

At how many hospitals or other research sites is this study being conducted?

"This study is taking place at 15 locations, with enrolment happening at Cedar-Sinai in Beverly Hills, JPS Health Network in Fort Worth, University of Colorado Denver in Aurora and 12 other sites."

Answered by AI

What is the standard application of T-DM1 in most patients?

"T-DM1 is most commonly used to treat breast cancer, but it can also be effective in the treatment of non-small cell lung carcinoma, malignant neoplasms, and postmenopause."

Answered by AI

Are investigators still looking for more participants?

"This particular study has stopped recruiting patients. It was originally posted on December 6th, 2018 but the last update was February 15th, 2022. 2716 other studies are actively looking for breast cancer patients and 176 studies need participants who specifically have T-DM1."

Answered by AI

What other medical tests have included T-DM1 as a possible treatment?

"T-DM1 has 176 ongoing studies with 26 in Phase 3. T-DM1 trials are conducted Burgas, New jersey as well as 11171 other locations."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
T-DM1 and Palbociclib for Metastatic HER2 Breast Cancer
2018. "T-DM1 and Palbociclib for Metastatic HER2 Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03530696.
~9 spots leftby Apr 2025
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