Study of Durvalumab, Olaparib, and Fulvestrant for Patients with ER-Positive, HER2-Negative Advanced Breast Cancer with Specific Genetic Alterations

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What is this study about?

This clinical trial is focused on studying a type of breast cancer known as ER-positive, HER2-negative breast cancer. This type of cancer can be either metastatic, meaning it has spread to other parts of the body, or locally advanced, meaning it has grown significantly in the breast or nearby areas. The study is particularly interested in patients who have specific genetic changes, such as mutations in the BRCA genes or other genes involved in a process called homologous recombination repair (HRR). These genetic changes can affect how the cancer responds to treatment.

The trial is testing a combination of three treatments: durvalumab, also known by its code name MEDI4736, olaparib, and fulvestrant. Durvalumab is given as an infusion into a vein, olaparib is taken as a tablet, and fulvestrant is given as an injection. The purpose of the study is to evaluate how effective this combination is in treating the specific type of breast cancer mentioned above. The study will also look at the safety of these treatments when used together.

Participants in the study will receive the treatments over a period of time, and their health will be monitored regularly. The main goal is to see if the cancer stops growing or shrinks within 24 weeks of starting the treatment. The study will also track how long patients live without the cancer getting worse and any side effects they might experience. This information will help doctors understand if this combination of treatments could be a good option for patients with this type of breast cancer in the future.

1 initial visit and consent

Upon joining the study, you will attend an initial visit where the study team will explain the trial in detail. You will be asked to provide written informed consent, confirming your understanding and willingness to participate in the study.

2 screening and baseline assessments

You will undergo various assessments to confirm eligibility, including blood tests, imaging scans, and a review of your medical history. These tests ensure that you meet the study criteria and establish baseline health data.

3 treatment initiation

Once eligibility is confirmed, you will begin the treatment phase. You will receive a combination of medications: fulvestrant as a 250 mg solution for injection administered intramuscularly, olaparib as 100 mg or 150 mg film-coated tablets taken orally, and durvalumab as a 50 mg/mL concentrate for solution for infusion administered intravenously. Additionally, goserelin acetate will be provided as a 3.6 mg implant administered subcutaneously.

4 treatment schedule

The treatment will be administered according to a specific schedule. Fulvestrant injections are typically given every two weeks for the first three doses, then once a month. Olaparib tablets are taken twice daily. Durvalumab infusions are given every four weeks. Goserelin acetate implants are administered every 28 days.

5 regular monitoring and assessments

Throughout the trial, you will have regular visits for monitoring your health and the effects of the treatment. This includes physical exams, blood tests, and imaging scans to assess the progression of the disease and any side effects.

6 end of treatment evaluation

At the end of the treatment period, a comprehensive evaluation will be conducted to assess the overall impact of the treatment on your condition. This includes final imaging scans and laboratory tests.

7 follow-up period

After completing the treatment, you will enter a follow-up period where your health will continue to be monitored at regular intervals. This helps to gather long-term data on the treatment’s effectiveness and any lasting effects.

Who Can Join the Study?

Must have a confirmed diagnosis of ER-positive (estrogen receptor-positive) and HER2-negative breast cancer that is either metastatic (spread to other parts of the body) or locally advanced (grown into nearby tissues).
Must be a woman of childbearing potential or a man, and agree to use effective birth control during the study and for 6 months after the last dose of the study drug.
Must provide written consent to participate in the study.
Must be willing and able to follow the study rules for the entire duration.
Must be at least 18 years old.
Must have a documented change in the BRCA1 or BRCA2 genes, or other specific gene changes related to HRR (homologous recombination repair) or MSI (microsatellite instability) status.
Must have a life expectancy of at least 16 weeks.
Must have an ECOG performance status of 0-1, which means being fully active or restricted in physically strenuous activity but able to carry out light work.
Must have at least one tumor that can be measured or evaluated by a CT scan or MRI.
In the case of metastatic cancer, must have received one line of hormone therapy with a CDK4/6 inhibitor and possibly one line of chemotherapy.
Must have adequate organ and bone marrow function, including specific levels of hemoglobin, neutrophils, platelets, bilirubin, liver enzymes (AST/ALT), and kidney function (creatinine clearance).
For women of childbearing potential, must have a negative pregnancy test within 28 days before starting the study treatment and confirmed on the first day of treatment.

Who Cannot Join the Study?

Patients who do not have ER-positive and HER2-negative breast cancer. ER-positive means the cancer grows in response to the hormone estrogen. HER2-negative means the cancer does not have high levels of the protein HER2.
Patients without a BRCA mutation. A BRCA mutation is a change in one of the BRCA genes, which can increase the risk of breast cancer.
Patients without changes in other genes involved in homologous recombination repair (HRR). HRR is a process that helps repair DNA damage in cells.
Patients without changes in MSI status. MSI stands for microsatellite instability, which is a condition of genetic hypermutability that can affect cancer development.
Patients who are not within the specified age range for the study.
Patients who are not female or male, as both genders are eligible.
Patients who are part of a vulnerable population, as they are not selected for this study.

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
Oncopole Claudius Regaud	Toulouse	France
Centr Georges Francois Leclerc	Dijon	France
Hospital Universitario Hm Sanchinarro	Madrid	Spain
Centre Jean Perrin	Clermont Ferrand	France
CHU Grenoble Alpes	La Tronche	France
Comite Entreprise Paul Papin	Angers	France
Institut Curie – Site Paris	Paris	France

Other Sites

Site Name	City	Country
Centre Antoine Lacassagne	Nice	France
Hospital Universitari General De Catalunya	Sant Cugat Del Valles	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Fundacion Instituto Valenciano De Oncologia	Valencia	Spain
Hospital San Pedro De Alcantara	Caceres	Spain
Grand Hopital De Charleroi	Charleroi	Belgium
Hospital Quironsalud Sagrado Corazon	Sevilla	Spain
Consorcio Hospitalario Provincial De Castellon	Castello De La Plana	Spain
Polyclinique De Limoges	Limoges	France
Institut De Cancerologie Strasbourg Europe	STRASBOURG, Alsace	France
Centre Henri Becquerel	Rouen	France
Hopital Prive Jean Mermoz	Lyon	France
Hospital Clinic De Barcelona	Barcelona	Spain
University Clinical Hospital Virgen De La Arrixaca	Murcia	Spain
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Hospital Son Llatzer	Palma	Spain
Hopital Prive Des Cotes D’armor	Plerin	France
Centre Hospitalier De Bourg-En-Bresse	Bourg En Bresse	France
Hospital Universitario De Canarias	La Laguna	Spain
Polyclinique Bordeaux Nord Aquitaine	Bordeaux	France
L’Hopital Prive Du Confluent	Nantes	France
Clinique Saint-Pierre Ottignies	Ottignies	Belgium
Ijijaevh Rbqjnvnl Dr Czzlak Dc Mcyfuwcupmp	Montpellier	France
Crbvqe Lmeh Bnhniq	Lyon	France
Coraqeywm Ucuophyvpabrpb Stxuwwbje	Woluwe-Saint-Lambert	Belgium
Agptpitqqc Pvvxudcc Htrocaoo Dm Pakne	Paris	France
Bxynyyut Uygsucmjed Hgvymrtd Cuxizk	Besançon	France
Hjmcpoma Uqffbkyfjnmwp Hucnmowu Thibz y Pehrgm Ipcpgyof Cawmnk dtxxsgnyxknkkqvxe (muiq	Badalona	Spain
Hpppnise Vrvw dguijjyv	Barcelona	Spain
Ikuduwxt Pidfignhkvgspxd Cjdwbb Cjgkrg	Marseille	France
Ckegnf Okvao Lnrusno	Lille	France

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	27.08.2019
France	Not recruiting	27.08.2019
Spain	Not recruiting	27.08.2019

Trial locations

Investigated drugs:

Durvalumab is a type of medication known as an immunotherapy. It works by helping your immune system recognize and attack cancer cells. In this trial, it is used to help your body fight breast cancer that is either metastatic, meaning it has spread to other parts of the body, or locally advanced, meaning it is large or has spread to nearby tissues.

Olaparib is a medication that targets cancer cells with specific genetic changes. It is known as a PARP inhibitor and works by preventing cancer cells from repairing themselves, which can lead to their death. This medication is used in this trial to treat breast cancer in patients who have certain genetic alterations that make their cancer more sensitive to this type of treatment.

Fulvestrant is a hormone therapy used to treat breast cancer. It works by blocking the effects of estrogen, a hormone that can promote the growth of breast cancer cells. In this trial, fulvestrant is used to help control the growth of cancer in patients with ER-positive breast cancer, which means the cancer cells grow in response to estrogen.

ER-positive and HER2-negative metastatic or locally advanced breast cancer with BRCA mutation or HRR/MSI gene alterations – 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). It can occur in a metastatic form, meaning it has spread to other parts of the body, or as locally advanced, where it has spread to nearby tissues or lymph nodes. The cancer is associated with mutations in the BRCA genes or other genes involved in homologous recombination repair (HRR) or microsatellite instability (MSI). These genetic alterations can affect the way cancer cells repair DNA damage, potentially leading to more aggressive tumor behavior. The disease progresses as cancer cells continue to grow and spread, potentially affecting various organs and systems in the body. The progression can vary widely among individuals, influenced by genetic factors and the cancer’s response to the body’s environment.

Trial ID:

2024-516847-23-00

Protocol code:

UC-0140/1812

NCT ID:

NCT04053322

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Durvalumab, Olaparib, and Fulvestrant for Patients with ER-Positive, HER2-Negative Advanced Breast Cancer with Specific Genetic Alterations

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?