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The safety and efficacy of this agent(s), or use in this setting, has not been established or is subject to confirmation. For an agent(s) whose safety and efficacy has not been established or confirmed, future regulatory approval or commercial availability is not guaranteed.

Clinical Trial Details

Geo Regions

Category

Breast Cancer

Atirmociclib (PF-07220060)

Atirmociclib (PF-07220060) is an investigational compound. Its safety and efficacy have not been established.

AN INTERVENTIONAL, OPEN-LABEL, RANDOMIZED, MULTICENTER, PHASE 2 STUDY OF PF-07220060 PLUS LETROZOLE COMPARED TO LETROZOLE ALONE IN POSTMENOPAUSAL WOMEN 18 YEARS OR OLDER WITH HORMONE RECEPTOR-POSITIVE, HER2-NEGATIVE BREAST CANCER IN THE NEOADJUVANT SETTING

Phase 2

NCT06465368

Active enrolling

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Locations

United States, Australia, Belgium, Italy, Korea, Republic of, Poland, Slovakia, Spain, Sweden, Taiwan

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Study design
Participant Group/Arm

EXPERIMENTAL: Arm A/Experimental/PF-07220060 plus letrozole

PF-07220060 given as tablet by mouth twice a day for 14 days. Letrozole given as tablet by mouth once a day for 14 days.

Intervention/Treatment

DRUG: PF-07220060

PF-07220060 given as tablet by mouth twice a day for 14 days.

DRUG: letrozole

Letrozole given as tablet by mouth once a day for 14 days

Participant Group/Arm

ACTIVE_COMPARATOR: Arm B/Control/letrozole

Letrozole given by mouth once a day for 14 days.

Intervention/Treatment

DRUG: letrozole

Letrozole given as tablet by mouth once a day for 14 days

Study design table for Clinical Trial
Key eligibility criteria
Inclusion criteria
  • Postmenopausal women with histologically confirmed HR-positive and HER2-negative BC (per local assessment)
  • Documented by estrogen receptor (ER) and/or progesterone receptor (PR)-positive disease by IHC or ISH
  • Participants must have Ki-67 score \>/=10% with unilateral, invasive T1c-T4c, N0-N2, M0 BC
  • Participants must be willing and able to undergo a baseline and Day 14 biopsy and must have an ECOG PS or 0 or 1.
  • Participants must be treatment naive for the treatment of BC and cannot have had prior treatment with any systemic therapy (e.g., chemotherapy, hormonal therapy), radiation, surgery, or any investigational agents or use of hormone replacement therapy (HRT) or any other estrogen-containing medication (including vaginal estrogen) within 2 weeks prior to diagnostic tissue sample taken.
Exclusion criteria
  • No prior systemic therapy, radiation, surgery, investigational therapy for treatment of breast cancer
  • Certain medical conditions in the previous 6 months, for example: myocardial infarction, severe unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack, symptomatic pulmonary embolism or other clinically significant episode of thromboembolism
  • Lab abnormalities outside protocol specified parameters
Key dates
Study start date
  • July 2024
Estimated Study Completion Date
  • October 2025
Key endpoints
Primary Outcome Measures
Outcome Measure

Rate of Ki-67

Measure Description

Centrally assessed biopsy

Time Frame

Day 14

Primary Outcome Measures table for Clinical Trial
Secondary Outcome Measures:
Outcome Measure

Incidence of Adverse Events (AEs)

Measure Description

Time Frame

Baseline, Day 14, and Day 28 post last treatment follow-up visit

Outcome Measure

Incidence of Serious AEs

Measure Description

Time Frame

Baseline, Day 14, and Day 28 post last treatment follow-up visit

Outcome Measure

Incidence of AEs leading to Discontinuation

Measure Description

Time Frame

Baseline, Day 14, and Day 28 post last treatment follow-up visit

Outcome Measure

Ctrough and peri-biopsy plasma concentrations of PF-07220060

Measure Description

Ctrough was defined as pre-dose serum concentration during multiple dosing and observed directly from data.

Time Frame

Pre-dose within 30 minutes and post-dose within 1 hour before or after biopsy

Outcome Measure

Circulating tumor DNA (ctDNA) measurements

Measure Description

Evaluate response on treatment

Time Frame

Baseline and Day 14

Outcome Measure

Percentage of Ki-67

Measure Description

All participants will have Ki-67 staining from the biopsy sample on Day 14 and Screening if not previously available

Time Frame

Screening and Day 14

Secondary Outcome Measures table for Clinical Trial
Number of participants

118

Collaborators and investigators

Sponsor: Pfizer

Collaborator: None

This information is current as of November 19th 2024.

Contact Us
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For more information, call or email the Pfizer Clinical Trial Contact Center:

1-800-887-7002 Email us

When calling, please reference this study number:

More Information Close NCT# stands for National Clinical Trial number. This is a unique identification code given to each clinical trial registered on ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419). Also called the ClinicalTrials.gov identifier. NCT06465368