BridgeMD
A Study to Learn About the Study Medicine Called PF-07220060 in Combination With Letrozole Compared to Letrozole Alone in Postmenopausal Women 18 Years or Older With HR-Positive, HER2-Negative Breast Cancer in the Neoadjuvant Setting
EU CTIS ID: 2024-512848-30-00
What this study is testing
Evaluate the effects of PF-07220060 plus letrozole and letrozole alone, respectively, on Ki-67 expression in tumors after 2 weeks of treatment.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Female participants ≥18 years (or the minimum age of consent in accordance with local regulations) with natural or surgical postmenopause at screening
- Histologically confirmed HR-positive and HER2-negative BC (per local assessment).
- Must have Ki-67 score ≥10% (analyzed locally).
- Must have unilateral, invasive T1c-T4c, N0-N2, M0 BC (AJCC; Version 8)
- ECOG PS 0 or 1.
- Willingness to undergo a baseline biopsy (if not done previously, which meets the sample collection requirement outlined in Section 8.2.1), and an on-treatment biopsy (per Section 8.7.1)
You likely can't join if
- Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or cervical carcinoma in situ.
- Prior and/or current prohibited treatment including: Systemic therapy (eg, chemotherapy, hormonal therapy), radiation, surgery, or any investigational agents for the treatment of BC.; Use of HRT or any other estrogen-containing medication (including vaginal estrogen) within 2 weeks prior to diagnostic tissue sample taken; Any live vaccines within 14 days of planned start of first dose of study intervention.; Current use or anticipated need for use of any prohibited food, supplements or concomitant medication(s) or participants unwilling or unable to use a required concomitant medication(s). Refer to Appendix 9.
- Previous administration with an investigational product within 2 weeks (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer). Participation in studies of other investigational products at any time during their participation in this study.
- Participants who are involuntarily incarcerated. (Note: Under certain specific circumstances a person who has been imprisoned may be included or permitted to continue as a participant. Strict conditions apply and Sponsor approval is required).
- Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
- Any of the following in the previous 6 months: 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
See the full eligibility criteria
Who can join
- Female participants ≥18 years (or the minimum age of consent in accordance with local regulations) with natural or surgical postmenopause at screening
- Histologically confirmed HR-positive and HER2-negative BC (per local assessment).
- Must have Ki-67 score ≥10% (analyzed locally).
- Must have unilateral, invasive T1c-T4c, N0-N2, M0 BC (AJCC; Version 8)
- ECOG PS 0 or 1.
- Willingness to undergo a baseline biopsy (if not done previously, which meets the sample collection requirement outlined in Section 8.2.1), and an on-treatment biopsy (per Section 8.7.1)
What rules you out
- Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or cervical carcinoma in situ.
- Prior and/or current prohibited treatment including: Systemic therapy (eg, chemotherapy, hormonal therapy), radiation, surgery, or any investigational agents for the treatment of BC.; Use of HRT or any other estrogen-containing medication (including vaginal estrogen) within 2 weeks prior to diagnostic tissue sample taken; Any live vaccines within 14 days of planned start of first dose of study intervention.; Current use or anticipated need for use of any prohibited food, supplements or concomitant medication(s) or participants unwilling or unable to use a required concomitant medication(s). Refer to Appendix 9.
- Previous administration with an investigational product within 2 weeks (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer). Participation in studies of other investigational products at any time during their participation in this study.
- Participants who are involuntarily incarcerated. (Note: Under certain specific circumstances a person who has been imprisoned may be included or permitted to continue as a participant. Strict conditions apply and Sponsor approval is required).
- Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
- Any of the following in the previous 6 months: 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
- Active inflammatory GI disease, chronic diarrhea, known uncontrolled diverticular disease or previous gastric resection or lap band surgery.
- History of allergy or reaction to any of the drug components for PF-07220060, letrozole (or other study medications), including participants with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
- Inability to take oral medication without crushing, dissolving, or chewing tablets.
- Participants with known active, bacterial, fungal, or viral infection, including (but not limited to) HBV, HCV, and known HIV or AIDS-related illness.
- Major surgery (as defined by the investigator) within 2 weeks of first dose of study intervention or has not recovered from major side effects.
- Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study.
- Inadequate bone marrow, renal, and/or liver function
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- Puerto Rico
- United States
- Brazil
- Canada
- Taiwan
- Argentina
- Korea, Republic of
- United Kingdom
- Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; Puerto Rico; United States; Brazil; Canada; Taiwan and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.