Study on Post-Neoadjuvant Therapy for Early Breast Cancer Using Ipatasertib, Inavolisib, and Atezolizumab for Patients with High-Risk Early Breast Cancer

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What is this study about?

This clinical trial is focused on studying treatments for early breast cancer. The study involves several medications, including Ipatasertib, Inavolisib (also known as GDC-0077), Tecentriq (which contains the active substance Atezolizumab), Phesgo (which contains Trastuzumab and Pertuzumab), Lynparza (which contains Olaparib), and Trodelvy (which contains Sacituzumab Govitecan). The purpose of the study is to improve outcomes for patients with high-risk early breast cancer by using treatments guided by specific biomarkers, which are indicators found in the body that can help predict how well a treatment might work.

Participants in the study will receive one or more of these treatments after they have already undergone initial therapy, surgery, and standard follow-up treatment. The study will last for up to 12 months, during which time participants will take the medications in the form of tablets or injections, depending on the specific treatment. Some participants may receive a placebo, which is a substance with no active medication, to help researchers compare the effects of the actual treatments.

The study aims to track the progress of participants over time, focusing on how long they remain free from cancer recurrence and their overall survival. Safety and any side effects experienced by participants will also be closely monitored. This research is part of a larger effort to tailor cancer treatments to individual patients based on their unique biological markers, potentially leading to more effective and personalized care.

1 joining the study

Upon joining the study, you will be required to provide written informed consent. This means you agree to participate after understanding the study’s purpose and procedures.

You will need to demonstrate the ability to understand and comply with the study protocol, which includes attending scheduled visits and undergoing examinations.

2 initial assessments

Initial assessments will be conducted to ensure you meet the study’s eligibility criteria. This includes tests to confirm adequate bone marrow, kidney, and liver function.

A performance status evaluation will be conducted to assess your general well-being and ability to carry out daily activities.

3 treatment phase

During the treatment phase, you will receive medications based on your specific condition. These may include ipatasertib and inavolisib in the form of film-coated tablets taken orally.

Other medications such as atezolizumab and sacituzumab govitecan will be administered through intravenous infusion, while trastuzumab and pertuzumab will be given as a subcutaneous injection.

The frequency and duration of medication administration will be determined by the study protocol and your specific treatment plan.

4 follow-up visits

Regular follow-up visits will be scheduled to monitor your health and the effects of the treatment. These visits will include physical examinations and laboratory tests.

You will be required to report any side effects or changes in your condition during these visits.

5 end of study participation

At the end of your participation in the study, a final assessment will be conducted to evaluate your overall health and the outcomes of the treatment.

You will receive information on any further steps or treatments that may be necessary based on the study’s findings.

Who Can Join the Study?

Provision of written informed consent, which means you agree to participate in the study after being informed about it.
Ability to understand and follow the study rules, including attending treatment sessions and scheduled visits.
Having adequate bone marrow, kidney, and liver function as shown by lab tests.
Being a female or male patient with non-metastatic early (stage I-III) breast cancer and aged 18 years or older.
Having completed chemotherapy before surgery and standard treatment after surgery, with or without radiotherapy, according to German guidelines (except for certain medications).
For patients with initially triple negative (TNBC) or HER2-positive breast cancer: Not achieving a complete response, which means some cancer cells are still present after initial treatment.
For patients with initially hormone receptor positive and HER2-negative breast cancer: Not achieving a complete response and having a specific score (CPS-EG score) of 3 or more with no cancer in lymph nodes, or a score of 2 or more with cancer in lymph nodes.
Having an ECOG Performance Status of 0 or 1, which means you are fully active or have some symptoms but can carry out light work.
Any side effects from previous treatments should have returned to their original state or be mild, except for those not considered a safety risk by the doctor.
Being postmenopausal or not able to have children. If you can have children, a negative pregnancy test is required, and you must use highly effective birth control methods.
If you or your partner can have children and are sexually active, you must agree to use two forms of birth control (a male condom and one highly effective method) starting immediately after signing the consent form and continuing throughout the study and for a specified time after.

Who Cannot Join the Study?

Patients who have not completed their initial treatment for early breast cancer cannot participate.
Patients who have not undergone surgery and standard therapy after initial treatment are excluded.
Patients who are not considered high-risk for early breast cancer are not eligible.
Patients who are not guided by specific biological markers for treatment are excluded.
Patients who are not in the age range specified for the study cannot participate.
Patients who are not able to follow the study procedures or attend follow-up visits are excluded.
Patients with other medical conditions that might interfere with the study are not eligible.
Patients who are pregnant or breastfeeding cannot participate.
Patients who are currently participating in another clinical trial are excluded.
Patients who have a history of certain medical conditions that could affect the study results 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
Technische Universitaet Dresden	Dresden	Germany
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany

Other Sites

Site Name	City	Country
Universitaetsklinikum Erlangen AöR	Erlangen	Germany
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Usxqloatjpndzzlsblqyd Eketn Ass	Essen	Germany
Ustjhofuqsyuiqzstmbgz Atjykopm	Augsburg	Germany
Umyouyzxnp Heuhvlah Cexztzo	Cologne	Germany
Uyjjbaxwrsesuiuqtjnjp Wjrwldwvh Aux	Wuerzburg	Germany

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	29.06.2023

Trial locations

Investigated drugs:

COGNITION-GUIDE is a clinical trial that aims to improve outcomes for patients with early high-risk breast cancer by using targeted therapies based on genetic information. This study involves several medications and therapies, each playing a specific role in the treatment process.

Targeted Therapy is a type of treatment that uses drugs or other substances to precisely identify and attack cancer cells, usually while doing little damage to normal cells. In this trial, targeted therapy is guided by the genetic makeup of the patient’s cancer, which helps in selecting the most effective treatment for each individual.

Post-Neoadjuvant Therapy refers to additional treatment given after the initial therapy (neoadjuvant therapy) and surgery. This therapy aims to eliminate any remaining cancer cells and reduce the risk of cancer returning. In this trial, the post-neoadjuvant therapy is tailored based on biomarkers, which are specific characteristics of the cancer cells that can be targeted by certain treatments.

Systemic Treatment involves using medication that travels through the bloodstream to reach and affect cells all over the body. This is important for treating cancer that may have spread beyond the original tumor site. In the context of this trial, systemic treatment is part of the post-neoadjuvant therapy to ensure comprehensive treatment of the cancer.

Investigated diseases:

Breast cancer

Early Breast Cancer – Early breast cancer refers to the initial stages of breast cancer where the disease is confined to the breast or has only spread to nearby lymph nodes. It typically begins as a small tumor or abnormal cells within the breast tissue. As the disease progresses, it may spread to the lymph nodes under the arm or near the collarbone. The progression of early breast cancer can vary, with some cases remaining localized for extended periods, while others may advance more rapidly. The disease is often detected through screening methods such as mammograms, which can identify tumors before they become palpable. Early detection is crucial as it can influence the course of the disease and potential outcomes.

Trial ID:

2024-514022-23-00

Protocol code:

DKFZ-2019-008

NCT ID:

NCT05332561

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Post-Neoadjuvant Therapy for Early Breast Cancer Using Ipatasertib, Inavolisib, and Atezolizumab for Patients with High-Risk Early Breast Cancer

What is this study about?

Who Can Join the Study?

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