A study of the investigational drug PF-07220060 together with Letrozole compared to Letrozole alone in postmenopausal women
Descrizione riassuntiva dello studio
The aim of this study is to investigate the effect of the investigational drug PF-07220060 plus Letrozole compared to the sole intake of Letrozole without PF-07220060 for the treatment of breast cancer. Participants will be randomly assigned (like flipping a coin) either to the treatment (PF-07220060 plus Letrozole) or to Letrozole alone. Both PF-07220060 and Letrozole will be taken orally. PF-07220060 will be taken twice daily for 14 days. Letrozole will be taken once daily for 14 days. Participants will have a pre-screening period of up to 28 days. If found eligible, they will receive a study treatment for 14 days and will then be invited for a follow-up approximately 28 days after the last dose. For all study participants, at least one biopsy will be performed during the study. A biopsy is the removal of cells or tissue for examination. A biopsy will be performed on all study participants on day 14. During the study, additional safety assessments, including blood draws and surveys by onsite staff, will be conducted.
(BASEC)
Intervento studiato
In the trial: Arm A/Experimental/PF-07220060 plus Letrozole
PF-07220060 will be taken orally in tablet form twice daily for 14 days. Letrozole will be taken orally in tablet form once daily for 14 days.
Active comparator: Arm B/Control/Letrozole
Letrozole will be taken orally once daily for 14 days.
(BASEC)
Malattie studiate
Breast cancer
(BASEC)
Postmenopausal women with histologically confirmed HR-positive and HER2-negative breast cancer (after local assessment) Documented estrogen receptor (ER) and/or progesterone receptor (PR) positive disease by IHC or ISH Participants must have a KI-67 score of >/= 10 % with unilateral, invasive T1c-T4c, N0-N2, and M0 breast cancer Participants must be willing and able to undergo a biopsy at baseline and on day 14 of the study, and they must have an ECOG score of 0 or 1. Participants must be eligible for breast cancer treatment and must not have received systemic therapy (e.g., chemotherapy, hormone therapy), radiation, surgery, or an investigational drug within 2 weeks prior to the collection of the diagnostic tissue sample, nor have used hormone replacement therapy (HRT) or another estrogen-containing medication (including vaginal estrogen). (BASEC)
Criteri di esclusione
A prior systemic therapy, radiation, surgery, investigational therapy for breast cancer Certain conditions in the past 6 months, e.g.: myocardial infarction, severe unstable angina pectoris, coronary/peripheral bypass surgery, symptomatic 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 Laboratory abnormalities outside the parameters specified in the protocol (BASEC)
Luogo dello studio
Aarau, Basilea, Berna, Losanna, Altro
(BASEC)
Baden
(BASEC)
Sponsor
Pfizer Inc 66 Hudson Boulevard East New York NY 10001 USA Sponsor’s representative in Switzerland: Martina Knecht Maier Pfizer AG Zürich
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Martina Knecht Maier
+41 78 615 62 56
martina.knechtmaier@clutterpfizer.comPfizer AG Schärenmoosstrasse 99 8052 Zürich Schweiz
(BASEC)
Informazioni scientifiche
non disponibile
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica Vaud
(BASEC)
Data di approvazione del comitato etico
16.12.2024
(BASEC)
ID di studio ICTRP
non disponibile
Titolo ufficiale (approvato dal comitato etico)
C4391025/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 (BASEC)
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Endpoint primari e secondari
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Inclusione del primo partecipante
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Risultati dello studio
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