Study of PF-07220060 and PF-07104091 with Endocrine Therapy for Patients with Advanced HR-positive HER2-negative Breast Cancer

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment for people with advanced solid tumors, including a specific type of breast cancer known as HR-positive HER2-negative metastatic or advanced breast cancer. The study involves a combination of medications, including two investigational drugs, PF-07220060 and PF-07104091, along with standard endocrine therapies like fulvestrant and letrozole. These medications are being tested to see how safe and tolerable they are when used together, as well as to understand their potential to fight cancer.

The purpose of the study is to evaluate the safety and tolerability of these medications in participants with advanced solid tumors. The study is divided into two parts. In the first part, participants will receive increasing doses of PF-07220060 and PF-07104091 to determine the most suitable dose for further testing. In the second part, the combination of these drugs with endocrine therapies will be tested in participants with HR-positive HER2-negative advanced or metastatic breast cancer. The study will monitor participants for any side effects and how their bodies respond to the treatment over a period of up to four months.

Participants will take the medications in the form of tablets or injections, depending on the specific drug. The study aims to gather information on how the drugs are processed in the body and their impact on the cancer. This research is important for developing new treatment options for people with advanced cancers, particularly those who have limited options available. The study is expected to continue until the end of 2026.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including age and diagnosis of advanced solid tumors.

Participants must have a measurable lesion that has not been previously treated with radiation.

2 initial assessment

An initial assessment is conducted to evaluate the current health status, including vital signs and laboratory tests.

This assessment helps establish a baseline for monitoring throughout the study.

3 treatment phase 1

The first phase involves the administration of increasing doses of PF-07220060 and PF-07104091 to determine the maximum tolerated dose.

Medications are taken orally in tablet form.

4 monitoring and evaluation

Participants are closely monitored for any side effects or adverse reactions.

Regular check-ups include laboratory tests and assessments of vital signs.

5 treatment phase 2

In the second phase, the combination therapy includes PF-07220060, PF-07104091, and endocrine therapy with either fulvestrant or letrozole.

Fulvestrant is administered as an intramuscular injection, while letrozole is taken orally.

6 ongoing assessment

Continuous assessment of safety and tolerability is conducted throughout the study.

Participants undergo regular evaluations to monitor the effectiveness of the treatment.

7 completion of study

The study is estimated to conclude by December 29, 2026.

Final assessments are conducted to evaluate the overall outcomes and any long-term effects of the treatment.

Who Can Join the Study?

Participants must be 18 years or older.
Must have a diagnosis of a locally advanced or metastatic solid tumor. This means the cancer has spread and cannot be removed by surgery.
Must have a lesion that can be evaluated. A lesion is an area of abnormal tissue.
For those in the expansion group, there must be at least one measurable lesion that has not been treated with radiation before. A measurable lesion is a tumor that can be measured in size.
The cancer type must be HR-positive HER2-negative or HR-positive HER2-positive. HR-positive means the cancer grows in response to hormones. HER2-negative or HER2-positive refers to whether the cancer has a protein that promotes growth.
Must have an advanced solid tumor or metastatic disease. Metastatic disease means the cancer has spread to other parts of the body.
Must have an ECOG PS of 0 or 1. ECOG PS is a scale that measures how well a person can perform daily activities. A score of 0 means fully active, and 1 means some symptoms but still able to do light work.

Who Cannot Join the Study?

Patients with a type of breast cancer that is not HR-positive or HER2-negative. HR-positive means the cancer grows in response to hormones. HER2-negative means the cancer does not have high levels of a protein called HER2.
Patients who do not have metastatic or advanced breast cancer. Metastatic means the cancer has spread to other parts of the body. Advanced means the cancer is in a later stage and may be more difficult to treat.
Patients who are not within the specified age range for the study.
Patients who are not part of the specified clinical trial group.
Patients who are not female or male, as both genders are included in the study.
Patients who are considered part of a vulnerable population, which means they may need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario Hm Sanchinarro	Madrid	Spain

Other Sites

Site Name	City	Country
Hospital Universitario 12 De Octubre	Madrid	Spain
Complex Oncological Center Plovdiv EOOD	Plovdiv	Bulgaria
Virgen del Rocío University Hospital	Sevilla	Spain
Hospital Clinic De Barcelona	Barcelona	Spain
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
University Hospital Olomouc	Olomouc	Czechia
Hleopvbr Vbwi dxgyssja	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Bulgaria	Not recruiting	20.03.2023
Czechia	Not recruiting	20.03.2023
Spain	Not recruiting	20.03.2023

Trial locations

Investigated drugs:

PF-07220060 is an investigational medication being studied for its potential to treat advanced solid tumors. It is being tested in combination with other treatments to evaluate its safety, tolerability, and effectiveness in shrinking or controlling tumors.

PF-07104091 is another investigational medication used in this study. It is combined with PF-07220060 to see how well the two medications work together in treating advanced solid tumors. The study aims to find the best dose that patients can tolerate while still being effective.

Fulvestrant is a type of endocrine therapy used in this trial. It is a hormone therapy that works by blocking the effects of estrogen in the body, which can help slow or stop the growth of certain types of breast cancer cells that need estrogen to grow.

Letrozole is also an endocrine therapy included in the study. It is used to lower estrogen levels in the body, which can help prevent the growth of hormone receptor-positive breast cancer cells. This medication is being tested in combination with the investigational drugs to assess its effectiveness in treating advanced breast cancer.

Investigated diseases:

Hormone Receptor-Positive, HER2-Negative Metastatic/Advanced Breast Cancer – This type of breast cancer is characterized by the presence of hormone receptors, meaning the cancer cells grow in response to hormones like estrogen or progesterone. It is HER2-negative, indicating that the cancer cells do not have an excess of the HER2 protein on their surface. This form of breast cancer can spread beyond the breast to other parts of the body, such as bones, liver, or lungs, which is referred to as metastatic or advanced stage. The progression of the disease can vary, with some patients experiencing slow growth and others facing more rapid advancement. The cancer’s behavior is influenced by the hormone receptor status, which can guide treatment decisions. Understanding the hormone receptor and HER2 status is crucial for determining the most effective management strategies.

Trial ID:

2023-509504-15-00

Protocol code:

C4391002

NCT ID:

NCT05262400

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of PF-07220060 and PF-07104091 with Endocrine Therapy for Patients with Advanced HR-positive HER2-negative Breast Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?