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Study of PF-07220060 and Letrozole for Postmenopausal Women with HR-Positive, HER2-Negative Breast Cancer

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What is this study about?

This clinical trial is focused on studying a type of breast cancer known as hormone receptor-positive, HER2-negative breast cancer. This type of cancer is characterized by the presence of hormone receptors and the absence of a protein called HER2 on the surface of the cancer cells. The study is being conducted in postmenopausal women who are 18 years or older. The treatment being tested involves a combination of two medications: PF-07220060 and letrozole. PF-07220060 is a new investigational drug, while letrozole is a medication commonly used to treat breast cancer by lowering estrogen levels in the body.

The purpose of the study is to compare the effects of the combination of PF-07220060 and letrozole with letrozole alone. Participants will receive either the combination treatment or letrozole by itself. The study will last for a period of two weeks, during which the effects of the treatments on the cancer cells will be closely monitored. The main focus is on observing changes in a specific protein called Ki-67, which is associated with cell growth, in the tumors after the treatment period.

Participants will be required to undergo certain procedures, including biopsies, which involve taking small samples of the tumor tissue to study the effects of the treatment. The study aims to provide valuable information on how the combination of PF-07220060 and letrozole affects breast cancer cells compared to letrozole alone, potentially leading to improved treatment options for this type of breast cancer in the future.

1 joining the study

Upon joining the study, you will be informed about the trial’s purpose and procedures. You will be asked to provide consent to participate.

You will undergo a screening process to confirm eligibility, which includes confirming your postmenopausal status and the specific type of breast cancer.

2 initial assessments

You will have a baseline biopsy, which involves taking a small sample of your tumor tissue for analysis.

Other initial assessments may include blood tests and imaging to establish a starting point for your treatment.

3 treatment phase

You will be randomly assigned to one of two groups: one group will receive PF-07220060 plus letrozole, and the other group will receive letrozole alone.

Letrozole is taken orally as a 2.5 mg film-coated tablet. The dosage and frequency of PF-07220060 will be explained to you by the study team.

The treatment will last for 14 days, during which you will continue to take the medication as instructed.

4 mid-treatment evaluation

On Day 14, you will undergo another biopsy to assess changes in the tumor.

Blood samples will be taken to measure the concentration of PF-07220060 in your system and to check for any changes in your condition.

5 monitoring and follow-up

Throughout the trial, you will be monitored for any side effects or adverse events. It is important to report any new symptoms or concerns to the study team.

You will have regular follow-up visits to assess your health and the effects of the treatment.

6 end of trial

At the end of the trial, you will have a final assessment to evaluate the overall impact of the treatment.

The study team will discuss the results with you and provide guidance on the next steps for your care.

Who Can Join the Study?

  • Participants must be female and at least 18 years old or the minimum age of consent according to local regulations.
  • Participants must be in postmenopause, which means they have stopped having menstrual periods, either naturally or due to surgery.
  • Participants must have a diagnosis of hormone receptor-positive, HER2-negative breast cancer. This means the cancer grows in response to hormones but does not have too much of the HER2 protein.
  • Participants must have a Ki-67 score of 10% or higher. Ki-67 is a measure of how quickly cancer cells are growing.
  • Participants must have a specific type of breast cancer that is unilateral (affecting one breast), invasive (cancer has spread into surrounding breast tissue), and classified as T1c-T4c, N0-N2, M0 according to the AJCC Version 8. This classification describes the size and extent of the cancer.
  • Participants must have an ECOG performance status of 0 or 1. This is a scale used to assess how well a person can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
  • Participants must be willing to undergo a baseline biopsy (a procedure to remove a small sample of tissue for testing) if it has not been done already, and an on-treatment biopsy during the study.

Who Cannot Join the Study?

  • Patients with any other type of cancer besides hormone receptor-positive, HER2-negative breast cancer cannot participate.
  • Men are not eligible to participate in this study.
  • Individuals under the age of 18 or over the age of 65 are not eligible.
  • Pregnant or breastfeeding women cannot participate.
  • Patients who have received any other cancer treatment within the last 2 weeks are not eligible.
  • Patients with severe or uncontrolled medical conditions that could interfere with the study are not eligible.
  • Patients who are unable to comply with the study procedures or follow-up visits are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Technische Universitaet Dresden Dresden Germany
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Hospital Universitario Hm Sanchinarro Madrid Spain
Katholieke Universiteit te Leuven Leuven Belgium
Hospital Jerez de la Frontera Jerez De La Frontera Spain
Comite Entreprise Paul Papin Angers France

Other Sites

Site Name City Country Status
Institut Jules Bordet Anderlecht Belgium
Istituto Europeo Di Oncologia S.r.l. Milan Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario 12 De Octubre Madrid Spain
Centre De Cancerologue Du Grand Montpellier Montpellier France
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku Bialystok Poland
Caritas Traegergesellschaft Saarbruecken mbH (CTS) Saarbrücken Germany
Nemocnica AGEL Komarno s.r.o. Komarno Slovakia
Karolinska University Hospital Solna Sweden
Narodny Onkologicky Ustav Bratislava Slovakia
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
Pratia S.A. Skorzewo Poland
Azienda Ospedaliero-Universitaria Maggiore Della Carita Novara Italy
Centre Hospitalier Lyon Sud Pierre Benite France
Centre De Lutte Contre Le Cancer Eugene Marquis Rennes France
Hospital Universitario Virgen De La Victoria Malaga Spain
Göteborgs Universitet Sahlgrenska Center for Cancer Research Gothenburg Sweden
Region Gaevleborg Gavle Sweden
Cnlpsdsel Uliridvkmjxpuj Sbmnmsrmg Woluwe-Saint-Lambert Belgium
Oovktlts &keqlmnfp Pnxetjxlyzwkdl Brindisi Italy
Mlmhym skiejd Banka Slovakia
Aetckke Uho Trhejlm nptr oopag Leghorn Italy
Aytaahx Sfp z ojsu Poznan Poland
Iavxdyuj Rgbwholez Pzi Lb Snsbvm Dic Tjpjui Duzp Avrnxwt Ijus Szralk Meldola Italy
Ufiitmg Uvuwigmbat Hcdvzvun Uppsala Sweden
Nnnpkvvu Imbmvefj Oeuijujng Ixl Mthba Sckqhcpkcgkkolyjlsuevulhfwxo Ivqlaujl Bflgzdbv Cracow Poland
Hiknsbhl Dd Ld Sxhkm Cbio I Scwo Pym Barcelona Spain
Uqgeqfbxpa Oi Ahkicjm Edegem Belgium
Ifvfmauh df Crcdldpcidai Htgsgckikiz Uovqszjrzefwc ds Szamy Edifhxt (rwpkpoa Saint Priest En Jarez France
Hemgmdfg Vpxz dhxhkxro Barcelona Spain
Iiolpooc Pcwiamjvtvbtpky Ciciqy Cxqvsc Marseille France
Wiwxglaoks Smabajh Ivp Scwdaei Pxp W Psvpnhtor Przemysl Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
15.10.2024
France France
Not recruiting
15.10.2024
Germany Germany
Not recruiting
15.10.2024
Italy Italy
Not recruiting
15.10.2024
Poland Poland
Not recruiting
15.10.2024
Slovakia Slovakia
Not recruiting
15.10.2024
Spain Spain
Not recruiting
15.10.2024
Sweden Sweden
Not recruiting
15.10.2024

Trial locations

Investigated drugs:

PF-07220060 is an experimental medication being studied for its potential to treat breast cancer. In this trial, it is being tested in combination with another medication to see if it can help reduce the growth of cancer cells in women who have a specific type of breast cancer. This medication is still under investigation, which means researchers are trying to understand how well it works and how safe it is for patients.

Letrozole is a medication commonly used to treat breast cancer in postmenopausal women. It works by lowering the levels of estrogen in the body, which can help slow down or stop the growth of certain types of breast cancer cells that need estrogen to grow. In this trial, letrozole is being used both alone and in combination with another medication to see how effective it is in reducing cancer cell growth.

Hormone Receptor-Positive, HER2-Negative Breast Cancer – This type of breast cancer is characterized by the presence of receptors for hormones like estrogen or progesterone, but it does not have an excess of the HER2 protein. The cancer cells grow in response to these hormones, which can influence the progression of the disease. It typically begins in the breast tissue and can spread to nearby lymph nodes or other parts of the body. The growth rate of this cancer can vary, and it may progress slowly or more rapidly depending on various factors. The absence of HER2 overexpression means that certain targeted therapies are not applicable. Understanding the hormone receptor status is crucial for determining the course of the disease.

Trial ID:
2024-512848-30-00
Protocol code:
C4391025
NCT ID:
NCT06465368
Trial Phase:
Therapeutic exploratory (Phase II)

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