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HER2-positive Breast CancerPhase 1/2NCT03709082

Palbociclib in Estrogen Receptor Positive (ER+) Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Metastatic Breast Cancer

A Phase 1/2 study testing Palbociclib 75mg, Letrozole 2.5mg and T-DM1 in people with HER2-positive Breast Cancer and Breast Cancer Metastatic, run by University of Kansas Medical Center at 5 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study will determine the recommend dose of palbociclib in combination with letrozole and another medication, Ado-trastuzumab emtansine (T-DM1). Additionally, researchers will determine how well this recommended dose will improve outcomes in this type of advanced breast cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Palbociclib 75mg, Letrozole 2.5mg and T-DM1
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
5 sitesUnited States
Study dates
15 Oct 2018to 3 Feb 2021
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pathologically confirmed diagnosis of Estrogen Receptor (ER) positive and HER2 (human epidermal growth factor receptor 2) positive metastatic breast cancer based on local laboratory results.
  • Prior treatment with a taxane (including paclitaxel, docetaxel and/or nanoparticle protein-bound paclitaxel).
  • Prior treatment with trastuzumab with or without pertuzumab.
  • Measurable or non-measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1.
  • Eastern Cooperative Oncology Group Performance Status of 0-2
  • Adequate organ and marrow function
  • Women must be post-menopausal
  • Must be able to swallow pills

Who cannot join

  • Current or anticipated use of other investigational agents
  • Prior therapy with a cyclin-dependent kinase 4/6 inhibitor
  • Subject has received chemotherapy or radiotherapy within 14 days prior to Cycle 1, Day 1 of the study or has not recovered from adverse events due to agents administered more than 14 days earlier
  • Subject has leptomeningeal disease
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to palbociclib or other agents used in study
  • Subject has other illness or disease that the investigator believes will interfere with study requirements.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • The University of Kansas Cancer Center, West Clinic

    Kansas City, Kansas, 66112

  • The University of Kansas Cancer Center, Westwood Campus

    Kansas City, Kansas, 66205

  • The University of Kansas Cancer Center, North Clinic

    Kansas City, Missouri, 64154

  • The University of Kansas Cancer Center, Lee's Summit Clinic

    Lee's Summit, Missouri, 64064

  • The University of Kansas Cancer Center, Overland Park Clinic

    Overland Park, Kansas, 66210

Other trials in United States

About this study

Official title: A Phase I/II Study of Palbociclib, Letrozole and T-DM1 in Trastuzumab Refractory Estrogen Receptor Positive (ER+) and HER2 Positive Metastatic Breast Cancer

This study will determine the recommend dose of palbociclib in combination with letrozole and another medication, Ado-trastuzumab emtansine (T-DM1). Additionally, researchers will determine how well this recommended dose will improve outcomes in this type of advanced breast cancer.

The study will include a safety lead-in with escalating dosing of palbociclib to determine the recommended phase II dose (RP2D) of palbociclib in this combination and an expanded phase II of palbociclib at the RP2D in combination with letrozole and Ado- trastuzumab Emtansine (T-DM1).

Read more

The starting dose of palbociclib will be 75 milligrams (mg) by mouth (PO) daily for each 21 day cycle. If 0 of 3 patients at the 75mg dose level experience a dose limiting toxicity (DLT), the next 3 patients will be enrolled at the next higher dosing cohort of 100mg PO daily for each 21 day cycle. If 0 of 3 patients at the 100mg dose level experience a DLT, the next 3 patients will be enrolled at the next higher dosing cohort of 125mg PO daily for each 21 day cycle. If 0 of 3 patients at the 125mg dose level experience a DLT, 125mg PO daily of palbociclib will be the phase II recommended dose used in the phase II expanded cohort. Patients receiving the phase II recommended dose in phase I will be enrolled in phase II of the study.

During safety lead-in and expanded phase II, Letrozole 2.5mg PO will be administered daily for each 21 day cycle and T-DM1 3.6 milligrams per kilograms intravenously (IV) will be administered on Day 1 of each 21 day cycle.

Being tested
Palbociclib 75mg, Letrozole 2.5mg, T-DM1, Palbociclib 100mg, Palbociclib 125mg
Keywords
palbociclib

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Palbociclib 75mgDrug

    Also called Ibrance

    Oral Administration

  • Letrozole 2.5mgDrug

    Also called Femara

    Oral Adminstration

  • T-DM1Drug

    Also called Ado-trastuzumab Emtansine, Kadcyla

    Intravenous Administration

  • Palbociclib 100mgDrug

    Also called Ibrance

    Oral Administration

  • Palbociclib 125mgDrug

    Also called Ibrance

    Oral Administration

  • PalbociclibDrug

    Also called Ibrance

    Oral Administration

Study groups in NCT03709082
Study groupRoleWhat they receive
Phase 1: Palbociclib 75 mgExperimentalPalbociclib 75 milligrams (mg) by mouth (PO) daily Letrozole 2.5 mg PO Daily Ado-trastuzumab Emtansine (T-DM1) 3.6 milligrams per kilograms (mg/kg) intravenous (IV) Day 1
Receives: Drug: Palbociclib 75mg; Drug: Letrozole 2.5mg; Drug: T-DM1
Phase 1: Palbociclib 100 mgExperimentalPalbociclib 100 milligrams (mg) by mouth (PO) daily Letrozole 2.5 mg PO Daily Ado-trastuzumab Emtansine (T-DM1) 3.6 milligrams per kilograms (mg/kg) intravenous (IV) Day 1
Receives: Drug: Letrozole 2.5mg; Drug: T-DM1; Drug: Palbociclib 100mg
Phase 1: Palbociclib 125 mgExperimentalPalbociclib 125 milligrams (mg) by mouth (PO) daily Letrozole 2.5 mg PO Daily Ado-trastuzumab Emtansine (T-DM1) 3.6 milligrams per kilograms (mg/kg) intravenous (IV) Day 1
Receives: Drug: Letrozole 2.5mg; Drug: T-DM1; Drug: Palbociclib 125mg
Phase 2: RP2DExperimentalRecommended Phase 2 dose (RP2D; determined during Phase 1 Safety Run In) Palbociclib by mouth (PO) daily Letrozole 2.5 mg PO Daily Ado-trastuzumab Emtansine (T-DM1) 3.6 milligrams per kilograms (mg/kg) intravenous (IV) Day 1
Receives: Drug: Letrozole 2.5mg; Drug: T-DM1; Drug: Palbociclib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of Overall Response

    Determine overall response rate (ORR), defined per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

    Measured: From the time of first documented complete response or appearance of one or more new lesions, until the first documented date of recurrent or progressive disease, whichever came first, assessed up to 5 years

Secondary outcomes (7)

  1. Proportion of participants with complete response (CR).

    Defined per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

    Measured: Up to 5 years

  2. Proportion of participants with partial response (PR).

    Defined per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

    Measured: Up to 5 years

  3. Proportion of participants with stable disease (SD).

    Defined per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

    Measured: Up to 5 years

  4. Proportion of participants with Grade 3 or higher adverse event.

    Defined per Common Terminology Criteria for Adverse Events (CTCAE) v4.03

    Measured: Up to 5 years

  5. Number of patients with adverse events

    Determine safety and tolerability of the intervention, defined per Common Terminology Criteria for Adverse Events (CTCAE) v4.03.

    Measured: Up to 5 years

  6. Number of participants with a worsening Patient Reported Outcomes of Adverse Events (PRO-AE) score

    PRO-AE score defined per Patient Reported Outcome Measurement Information System (PROMIS) and Breast Cancer Prevention Trial (BCPT) Symptom Checklist.

    Measured: At baseline and Day 1 of each cycle, up to 5 years (each cyle is 21 days)

  7. Peak observed plasma concentration

    Defined per maximum observed concentration (Cmax) and time of Cmax (Tmax).

    Measured: Cycle 1, Day 1: 0 ,2,4 and 8 hours post treatment; Cycle 1, Day 15: 0 hours post treatment (each cyle is 21 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2018
  2. Study start15 Oct 2018
  3. Primary completion12 Mar 2020
  4. Study completion3 Feb 2021

Why it stopped: Low accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03709082
Sponsor's protocol ID
2017-IIT-HER2-Aspire
Status last verified
Mar 2024
First submitted
9 Oct 2018
Last updated
5 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Palbociclib 75mg, Letrozole 2.5mg and T-DM1 in people with HER2-positive Breast Cancer and Breast Cancer Metastatic, run by University of Kansas Medical Center at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Low accrual). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Overall Response (time frame: From the time of first documented complete response or appearance of one or more new lesions, until the first documented date of recurrent or progressive disease, whichever came first, assessed up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03709082.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.

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