Study of inavolisib, ribociclib, and fulvestrant for patients with advanced hormone-receptor-positive, HER2-negative breast cancer.

2 1 1

What is this study about?

This study focuses on a type of Advanced Breast Cancer that is Hormone-Receptor-Positive and HER2-Negative. This means the cancer cells grow in response to certain hormones and do not have an excess of a specific protein called HER2. The condition is also Endocrine-Resistant, meaning the cancer has stopped responding to hormone therapy, and it involves a Chromosome 8p Loss, which is a change in the genetic material of the cells. Additionally, the cancer does not have a PIK3CA Mutation, which is a specific change in a gene that often drives cancer growth.

The purpose of the study is to evaluate the effectiveness and safety of a combination of three medications. One group will receive Inavolisib, Ribociclib, and Fulvestrant, while another group will receive a placebo along with Ribociclib and Fulvestrant. Inavolisib and Ribociclib are taken as pills, while Fulvestrant is given as an injection into the muscle.

Participants in the study will be assigned to one of the two treatment groups. Over the course of the study, the combination of drugs will be monitored to see how the cancer responds and to observe any side effects. The study will track how long the cancer stays stable and how long patients live while receiving these treatments.

Who Can Join the Study?

  • The patient must be a woman or a man with a confirmed diagnosis of breast cancer that has either spread to other parts of the body or is at an advanced stage where surgery or radiation cannot fully cure it.
  • The cancer must be hormone receptor-positive, which means at least 1% of the cancer cells react to the hormones estrogen or progesterone.
  • The patient must not have undergone any previous systemic therapy, which is medicine that travels through the entire body (like chemotherapy or hormone therapy), to treat their advanced or spreading breast cancer.
  • The patient must have had their cancer get worse while taking endocrine-based treatment (hormone therapy) or within 12 months after finishing such treatment with medications like aromatase inhibitors or tamoxifen.
  • Testing of the tumor tissue must show that the cancer does not have a specific genetic change called a PIK3CA mutation.
  • Testing must confirm the presence of heterozygous loss of chromosome 8p, which is a specific type of missing genetic material on a part of a cell’s structure called a chromosome.
  • The cancer must include measurable disease, meaning the tumors are large enough and in locations that allow doctors to clearly track their size using standard medical rules.

Who Cannot Join the Study?

  • Having metaplastic breast cancer, which is a rare and aggressive type of breast cancer.
  • Receiving radiotherapy, which is a treatment using high doses of radiation to kill cancer cells, within 2 weeks before being assigned to a study group.
  • Being a candidate for cytotoxic chemotherapy, which is a type of strong medicine used to kill fast-growing cells, based on local medical rules.
  • Experiencing a visceral crisis, which is a sudden and severe medical emergency caused by cancer affecting internal organs like the liver or lungs.
  • Having Type 2 diabetes that requires ongoing medication, or having any history of Type 1 diabetes.
  • Having active CNS metastases, which means cancer has spread to the central nervous system (the brain or spinal cord) and is currently growing or causing symptoms.
  • Needing anticonvulsants, which are medicines used to prevent seizures, or corticosteroids, which are powerful anti-inflammatory medicines, to control symptoms of brain cancer.
  • Having any history of leptomeningeal disease or carcinomatous meningitis, which are conditions where cancer cells spread into the fluid surrounding the brain and spinal cord.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Oncopole Claudius Regaud Toulouse France
Universitaetsklinikum Heidelberg AöR Heidelberg Germany

Other Sites

Site Name City Country Status
Franziskus Hospital Harderberg Georgsmarienhütte Germany
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Universitaetsklinikum Aachen AöR Aachen Germany
Hospital Universitario 12 De Octubre Madrid Spain
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli Lublin Poland
Instytut Centrum Zdrowia Matki Polki Lodz Poland
Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku Bialystok Poland
Foundation Medicine GmbH Penzberg Germany
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Ospedale San Raffaele S.r.l. Milan Italy
Universita’ Campus Bio-medico Di Roma Rome Italy
Hospital Clinic De Barcelona Barcelona Spain
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Iwdqmpee Rkgoleoq De Cvxcyh Dn Miinmkexkbf Montpellier France
Cuhvch Lysb Bqytrb Lyon France
Ugqknwubcjaumhjoacozi Ebxol Aqo Essen Germany
Ichgavdr Cewchu Dwjpjrnwrslbthmsz L'hospitalet De Llobregat Spain
Dlkpdoiklbad Cwcqpoc Obyvfrwds Plmgirujtszt I Hxewfkviaxu Wroclaw Poland
Istkbfmz Rnjurxloy Pio Lh Skipoe Dcv Tnidue Dwqw Adniwgt Ibtt Slitns Meldola Italy
Aamfcam Oowyzdrpgrb Pynb Gnhnkvjy Xkplu Bergamo Italy
Mqe Mfozieo Cqxupw Dvtrmyvdzdd Gfuo Duesseldorf Germany
Inysqyfd Pyhqctwogywyxdy Cnqtdq Cemlza Marseille France
Cunnyi Ourfi Lzvmadb Lille France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
15.04.2026
Germany Germany
Recruiting
15.04.2026
Italy Italy
Recruiting
15.04.2026
Poland Poland
Recruiting
15.04.2026
Spain Spain
Recruiting
15.04.2026

Trial locations

Inavolisib is a medication taken by mouth that is being studied to see if it can help treat certain types of advanced breast cancer by targeting specific pathways in the cells.

Ribociclib is a pill taken daily that helps to slow down the growth of cancer cells by blocking specific signals that allow the cancer to multiply.

Fulvestrant is a medication given by injection into the muscle that works by blocking the effects of hormones that certain breast cancers use to grow.

Investigated diseases:

Endocrine-Resistant Hormone-Receptor-Positive, HER2-Negative Advanced Breast Cancer with Chromosome 8p Loss and Without PIK3CA Mutation – This is a type of breast cancer where the cells grow in response to hormones like estrogen or progesterone. It is characterized by a lack of the HER2 protein on the cell surface. Over time, the cancer may stop responding to standard hormone-based therapies. Specific genetic changes, such as the loss of part of chromosome 8, may be present in the tumor cells. This particular form does not have a specific mutation in the PIK3CA gene. The disease progresses as cancer cells continue to multiply and spread within the body.

Trial ID:
2025-523013-28-00
Protocol code:
CO46274
Trial Phase:
Therapeutic exploratory (Phase II)

Other Trials to Consider

  • A study to evaluate the use of [68Ga]BED003 for imaging colorectal, gastric, pancreatic, breast, and ovarian cancers.

    Recruiting

    2 1 1
    Italy The Netherlands
  • A study to test the safety and effectiveness of ONA-255 in patients with advanced cancer including breast cancer and gastric cancer

    Recruiting

    2 1 1
    Spain