Study of Giredestrant, Triptorelin, and Anastrozole in Premenopausal Women with ER-Positive/HER2-Negative Early Breast Cancer

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What is this study about?

This clinical trial is focused on studying treatments for ER-positive/HER2-negative early breast cancer in premenopausal women. The study will explore the effects of different hormone therapies, including Giredestrant (also known by its code name RO7197597), Triptorelin, and Anastrozole. These medications are used to manage hormone levels and slow the growth of cancer cells. Giredestrant is a type of medication known as a selective estrogen receptor degrader (SERD), which helps to block the effects of estrogen on cancer cells. Triptorelin is a gonadotropin-releasing hormone (GnRH) agonist that reduces the production of certain hormones, and Anastrozole is an aromatase inhibitor that lowers estrogen levels in the body.

The purpose of this study is to determine if a combination of Giredestrant and Triptorelin is more effective in reducing cancer cell growth compared to a combination of Anastrozole and Triptorelin. Additionally, the study will assess if Giredestrant alone can provide similar benefits as when it is combined with Triptorelin. Participants will receive these treatments over a period of four weeks. The study will involve taking medication either orally or through an injection, depending on the specific treatment being tested.

Throughout the study, participants will undergo regular monitoring to assess the effects of the treatments on their cancer. This will include taking samples from the tumor before and after the treatment period to evaluate changes in cancer cell activity. The study aims to provide valuable insights into the effectiveness of these hormone therapies in managing ER-positive/HER2-negative early breast cancer in premenopausal women.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including age, premenopausal status, and breast cancer characteristics.

A pregnancy test is conducted before starting the treatment to ensure safety.

2 initial biopsy

A biopsy of the tumor is performed to collect a sample for analysis. This helps in assessing the tumor’s characteristics before treatment.

3 treatment phase

The treatment involves taking medications for a period of 4 weeks.

One group receives giredestrant in capsule form, taken orally, possibly combined with triptorelin, which is administered as an injection into the muscle.

Another group receives anastrozole in tablet form, taken orally, along with triptorelin injections.

4 post-treatment biopsy

After completing the treatment, a second biopsy is conducted to evaluate changes in the tumor.

5 analysis and follow-up

The primary focus is on the change in the Ki-67 index, which measures cell growth activity, between the initial and post-treatment biopsies.

Secondary evaluations include assessing complete cell cycle arrest and monitoring any adverse events.

Who Can Join the Study?

Must be a premenopausal woman aged 18 years or older. Premenopausal means still having regular menstrual periods.
Must have a type of breast cancer called ER-positive/HER2-negative. This means the cancer cells have certain characteristics related to hormone receptors.
The breast cancer must be operable, meaning it can be treated with surgery.
Eligible for breast surgery, either breast-conserving surgery or mastectomy. The cancer should be in stage I, II, or operable stage III, but not stage T4.
The tumor must be at least 1.0 cm in size.
Can have multiple tumors in one or both breasts, but the same tumor area must be checked before and after treatment.
Cannot have cancer that has spread to other parts of the body (no distant metastatic disease).
The tumor must have at least 1% of cells that are estrogen receptor (ER)-positive.
The tumor must be HER2-negative, meaning it does not have high levels of a protein called HER2.
The tumor must have a Ki-67 level of 10% or more. Ki-67 is a marker that shows how fast cancer cells are growing.
Must have an ECOG Performance Status of 0-1, which means being fully active or having some symptoms but still able to do light work.
Must have a resting heart rate of 40 beats per minute or more.
Must have normal blood, kidney, and liver function.
Must have a negative pregnancy test within 5 weeks before starting the study and again on the first day of treatment.
Women who can become pregnant must use highly effective birth control during the study and for 10 days after the last dose.
Must sign a Written Informed Consent, agreeing to participate in the study.
Must agree to provide tumor and blood samples for further study and review.

Who Cannot Join the Study?

Patients who are not premenopausal. Premenopausal means before menopause, which is the time when a woman’s menstrual periods stop permanently.
Patients who do not have ER-positive/HER2-negative early breast cancer. ER-positive means the cancer cells grow in response to the hormone estrogen. HER2-negative means the cancer cells do not have high levels of the protein HER2.
Patients who are male, as the study is only for female patients.
Patients who are not considered part of the vulnerable population selected for this study. Vulnerable population refers to groups of people who may be at a higher risk of harm or exploitation in research.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Hospital Universitario Hm Sanchinarro	Madrid	Spain

Other Sites

Site Name	City	Country
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Helios Universitaetsklinikum Wuppertal	Wuppertal	Germany
Universitaetsklinikum Ulm AöR	Ulm	Germany
Azienda USL Toscana Centro	Prato	Italy
Cliniche Gavazzeni S.p.A.	Bergamo	Italy
Azienda Ospedaliero-Universitaria Maggiore Della Carita	Novara	Italy
Azienda Unita Sanitaria Locale Della Romagna	Rimini	Italy
Klinikum Suedstadt Rostock	Rostock	Germany
St James’s Hospital	Dublin	Ireland
Azienda Sanitaria Locale Di Taranto	Taranto	Italy
Orszagos Onkologiai Intezet	Budapest	Hungary
University Hospital Galway	Galway	Ireland
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Universita’ Politecnica Delle Marche	Ancona	Italy
Fondazione Salvatore Maugeri Clinica Del Lavoro E Della Riabilitazione	Pavia	Italy
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
HELIOS Klinikum Berlin-Buch GmbH	Berlin	Germany
Servei De Salut De Les Illes Balears	Palma	Spain
Praxisklinik Krebsheilkunde Fuer Frauen	Berlin	Germany
St. Elisabeth-Krankenhaus Leipzig	Leipzig	Germany
Göteborgs Universitet Sahlgrenska Center for Cancer Research	Gothenburg	Sweden
Idjgryuu Rdzbggkwe Pis Lt Szvkyu Dno Tbrpmf Dcri Aaqkggq Ijmd Sefbuu	Meldola	Italy
Cfvu Ualbkxpkld Hezwbram	Cork	Ireland
Hngdette Uaxbzlrcgbcyq dg Bmghgjh	Badajoz	Spain
Hwveosny Uznbwwfubcnbt Avqtf da Vnqhmrkm	Lleida	Spain
Govzsw Uzgzqavnbe Fzldtgura	Frankfurt	Germany
Iiwjlfdm Cblquv Dzlvsorbigpbutlup	L'hospitalet De Llobregat	Spain
Kdvuzfxa Eoocmwxsewxurpfjsqxmhsml Hfimvdsyymeqsaqth	Essen	Germany
Htqfaqal Uesjhoinespbh Hfciusyg Thuhb y Pvkplx Inlhrsmh Cclidp dnjbwxmffrozjcifi (jbvy	Badalona	Spain

Trial status

Country	Status	Recruitment Start
France	Not recruiting	01.12.2023
Germany	Not recruiting	01.12.2023
Hungary	Not recruiting	01.12.2023
Ireland	Not recruiting	01.12.2023
Italy	Not recruiting	01.12.2023
Spain	Not recruiting	01.12.2023
Sweden	Not recruiting	01.12.2023

Trial locations

Investigated drugs:

Giredestrant is a medication being studied for its potential to reduce the growth of cancer cells in patients with early breast cancer. It is being tested to see if it can effectively slow down or stop the proliferation of cancer cells in premenopausal women with ER-positive/HER2-negative breast cancer.

Triptorelin is a therapy used to lower certain hormone levels in the body. In this trial, it is combined with other treatments to see if it enhances their effectiveness in reducing cancer cell growth in premenopausal women with ER-positive/HER2-negative breast cancer.

Anastrozole is a medication that helps to lower estrogen levels in the body, which can slow or stop the growth of certain types of breast cancer cells. It is being used in combination with triptorelin in this trial to evaluate its effectiveness in treating premenopausal women with ER-positive/HER2-negative breast cancer.

ER-positive/HER2-negative early breast cancer – This type of breast cancer is characterized by the presence of estrogen receptors (ER-positive) and the absence of human epidermal growth factor receptor 2 (HER2-negative) on the cancer cells. It typically occurs in the early stages of breast cancer development. The cancer cells grow in response to estrogen, which can influence the progression of the disease. This subtype of breast cancer is often considered less aggressive than HER2-positive types. The progression involves the growth and potential spread of cancer cells within the breast tissue and possibly to nearby lymph nodes. Understanding the hormone receptor status is crucial for determining the course of the disease.

Trial ID:

2022-503013-32-00

Protocol code:

67-22 PREcoopERA

NCT ID:

NCT05896566

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Giredestrant, Triptorelin, and Anastrozole in Premenopausal Women with ER-Positive/HER2-Negative Early Breast Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?