Study of inavolisib, letrozole and ribociclib in untreated early-stage breast cancer patients with PIK3CA mutation

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What is this study about?

This clinical trial focuses on patients with early-stage breast cancer that has a specific genetic change called PIK3CA mutation. The cancer type being studied is also characterized as being estrogen receptor-positive and HER2-negative, which refers to specific features of the tumor cells that help determine the most appropriate treatment approach.

The study will test a new drug called inavolisib (also known as GDC-0077) in combination with other medications including letrozole and ribociclib. These medications are given as tablets that patients take by mouth. The treatment is given before surgery, which is known as neoadjuvant treatment, to see if it can help shrink the tumor.

The main purpose of this study is to understand how safe these drug combinations are and how well patients can tolerate them. During the study, patients will receive treatment for up to 6 months. Doctors will monitor patients’ health through regular check-ups and laboratory tests. They will also examine how well the treatment works by measuring changes in the tumor and checking for any side effects that patients may experience.

1 Initial treatment phase

You will receive oral medication consisting of two types of film-coated tablets: inavolisib combined with either letrozole or ribociclib

The treatment is designed for patients with early-stage breast cancer that has a specific genetic change called PIK3CA mutation

Your treatment will be given before surgery, which is called neoadjuvant treatment

2 Monitoring during treatment

Regular laboratory tests will be conducted to monitor your health

Your tumor response to treatment will be evaluated through medical examinations

You will be asked to report any side effects you experience

Your daily function and quality of life will be assessed through questionnaires

3 Assessment of treatment effectiveness

Your tumor response will be measured through medical examinations

A test called Ki-67 will be performed to measure cell growth in the tumor

The medical team will monitor how well you tolerate the treatment and may adjust medication doses if needed

4 Surgical phase

After completing the medication phase, you will undergo breast surgery

The surgery may be either a mastectomy (removal of the entire breast) or breast-conserving surgery

The removed tissue will be examined to determine how well the treatment worked

5 Final evaluation

The success of the treatment will be assessed by examining the tissue removed during surgery

A complete evaluation of your response to treatment will be performed

The study is expected to continue until March 31, 2027

Who Can Join the Study?

You must have Stage II-III breast cancer that has been confirmed through tissue examination
You must be suitable for neoadjuvant treatment (treatment given before main surgery) combined with hormone therapy
You must be willing to undergo breast surgery (either removal of the whole breast or part of it) after the initial treatment, unless surgery is not possible
Your tumor must be ER-positive (responds to the hormone estrogen), with at least 1% of cancer cells showing this characteristic
Your tumor must be HER2-negative (does not have high levels of a protein called HER2)
Your tumor must have a Ki-67 score (a measure of cancer cell growth) of at least 5%
Your tumor must have a confirmed PIK3CA mutation (a specific genetic change), which will be tested in a laboratory using a sample of your tumor tissue
You must be female
You must be an adult (18 years or older)

Who Cannot Join the Study?

Male patients (study is for female patients only)
Patients younger than 18 years old
Patients who do not have a confirmed PIK3CA mutation (a specific genetic change) in their breast cancer
Patients who do not have early-stage breast cancer
Patients with known allergies or severe reactions to inavolisib (the study medication) or similar drugs
Pregnant or breastfeeding women
Patients with severe liver or kidney problems
Patients currently participating in other clinical trials
Patients who have received other cancer treatments in the past 30 days
Patients with uncontrolled heart conditions
Patients with serious medical conditions that could interfere with the study treatment
Patients unable to follow study procedures or attend regular check-ups
Patients with a history of other cancers in the past 5 years (except for successfully treated non-melanoma skin cancer or cervical cancer in situ)

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Technische Universitaet Dresden	Dresden	Germany
Hospital Universitario De Salamanca	Salamanca	Spain
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany

Other Sites

Site Name	City	Country
St. Vincenz-Krankenhaus GmbH	Paderborn	Germany
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
HELIOS Kliniken Schwerin GmbH	Schwerin	Germany
HELIOS Klinikum Berlin-Buch GmbH	Berlin	Germany
Hospital Clinic De Barcelona	Barcelona	Spain
Philipps-Universitaet Marburg	Marburg	Germany
Kednwegd Epcaqhjfuzzpvhlmmpuahdac Hlgiyemctlccfwoql	Essen	Germany
Dgi Oayvbwbts Gbkj	Berlin	Germany
Hanlsazn Vhdk dbawiecm	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	01.07.2025
Spain	Not recruiting	01.07.2025

Trial locations

Investigated drugs:

Inavolisib is a targeted therapy medication used in breast cancer treatment. It belongs to a class of drugs that specifically target PIK3CA mutations, which are genetic changes found in some breast cancers. This medication works by blocking specific proteins that contribute to cancer cell growth. It is being studied as a neoadjuvant treatment, which means it is given before the main treatment (usually surgery) to help shrink the tumor.

The trial studies Inavolisib in combination with other breast cancer treatments, though the specific combination medications are not specified in the provided data. This combination approach is being tested to determine how safe and effective it is for treating early-stage breast cancer that has PIK3CA mutations, before the patient undergoes surgery.

Investigated diseases:

Breast cancer

Early-Stage Breast Cancer with PIK3CA Mutation – A form of breast cancer characterized by specific genetic changes in the PIK3CA gene, occurring in the early phase of the disease. This type of cancer begins when cells in the breast tissue start growing abnormally due to mutations in the PIK3CA gene, which plays a role in cell growth and division. The condition typically develops in the milk ducts or milk-producing glands of the breast. Early-stage refers to cancer that remains localized within the breast or has only spread to nearby lymph nodes. The presence of PIK3CA mutations can affect how the cancer cells grow and respond to signals that control cell division.

Trial ID:

2024-518811-20-00

Protocol code:

BO45853

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of inavolisib, letrozole and ribociclib in untreated early-stage breast cancer patients with PIK3CA mutation

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?