Comparing inavolisib plus fulvestrant versus alpelisib plus fulvestrant in patients with advanced hormone receptor-positive, HER2-negative breast cancer with PIK3CA mutation

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What is this study about?

This study focuses on treating hormone receptor-positive, HER2-negative, PIK3CA mutated, locally advanced or metastatic breast cancer that has progressed during or after previous treatments. The study compares two treatment combinations: inavolisib plus fulvestrant versus alpelisib plus fulvestrant. These medications belong to a class of drugs called kinase inhibitors that work by blocking specific proteins involved in cancer growth.

The main purpose of this research is to determine how well inavolisib combined with fulvestrant works compared to alpelisib combined with fulvestrant in treating this specific type of breast cancer. The study will measure how long patients live without their cancer getting worse. Other aspects being studied include overall survival time, how well tumors respond to treatment, and how the treatments affect patients’ quality of life.

Participants will receive either inavolisib or alpelisib pills taken by mouth daily, along with fulvestrant given as an intramuscular injection. During the study, patients will have regular medical check-ups and tests to monitor their cancer and any side effects from the treatment. The effectiveness of the treatment will be assessed through various medical examinations and imaging tests.

1 Initial medication assignment

You will be randomly assigned to receive one of two treatment combinations:

Group 1: Inavolisib tablets taken by mouth plus Fulvestrant given as an intramuscular injection

Group 2: Alpelisib (Piqray) tablets taken by mouth plus Fulvestrant given as an intramuscular injection

2 Treatment schedule

You will take your assigned oral medication (either Inavolisib or Alpelisib) daily

Fulvestrant injections will be administered at scheduled clinic visits

Your doctor will determine the specific dosing schedule based on your treatment group

3 Regular monitoring

Your cancer progression will be regularly assessed through imaging scans

Blood tests will be performed to monitor your health and medication levels

Your doctor will evaluate any side effects you may experience

You will complete questionnaires about your pain levels and daily activities

4 Ongoing assessments

Regular checks of your physical condition and ability to perform daily activities

Monitoring of your overall health status

Assessment of how well the treatment is working against your cancer

5 Treatment duration

Treatment will continue as long as your cancer does not worsen

Your doctor may adjust or stop treatment based on how your body responds

The study is planned to continue until March 2029

Who Can Join the Study?

  • You must have advanced breast cancer (metastatic adenocarcinoma) that cannot be treated with surgery or radiation therapy alone
  • Your breast cancer must be hormone receptor-positive and HER2-negative, confirmed by laboratory testing
  • Your tumor must have specific genetic changes (mutations) in the PIK3CA gene, which will be confirmed by a special test
  • You must have previously received treatment with:
    • A combination of hormone therapy and CDK4/6 inhibitor (a type of targeted therapy)
    • No more than 2 previous treatments for metastatic breast cancer
    • You may have had one course of chemotherapy for metastatic breast cancer
  • Your cancer must be measurable or able to be evaluated by scanning tests
  • Your overall physical condition must be good enough to perform daily activities, with an ECOG score of 0-2 (a scale that measures how well you can perform daily activities)
  • You can be either male or female
  • You must be an adult (18 years or older)

Who Cannot Join the Study?

  • Patients who have not been diagnosed with metastatic breast cancer (cancer that has spread beyond the breast)
  • Individuals under 18 years of age
  • Patients who have had previous treatment with alpelisib (a targeted cancer therapy)
  • Patients with untreated or active brain metastases (cancer that has spread to the brain)
  • Individuals with severe heart conditions or uncontrolled cardiovascular disease
  • Patients with uncontrolled diabetes mellitus (high blood sugar levels)
  • Those with serious active infections
  • Patients participating in other clinical trials
  • Individuals with known allergies to the study medications
  • Patients with severely impaired liver or kidney function
  • Pregnant or breastfeeding women
  • Patients unable to swallow oral medications
  • Individuals with conditions that would interfere with study participation or evaluation

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Universitaetsmedizin Goettingen Goettingen Germany
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Oncopole Claudius Regaud Toulouse France
Centr Georges Francois Leclerc Dijon France
Katholieke Universiteit te Leuven Leuven Belgium
Medizinische Hochschule Hannover Hanover Germany
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie Koszalin Poland

Other Sites

Site Name City Country Status
Ospedale San Raffaele S.r.l. Milan Italy
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
Centre Hospitalier De La Cote Basque Bayonne France
Azienda Provinciale Per I Servizi Sanitari Trento Italy
Grand Hopital De Charleroi Charleroi Belgium
Franziskus Hospital Harderberg Georgsmarienhütte Germany
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy Warsaw Poland
Ludwig Maximilian University Of Munich Munich Germany
Universidade De Santiago De Compostela Santiago De Compostela Spain
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Cracow Poland
Azienda Ospedaliera Sant Anna E San Sebastiano Di Caserta Caserta Italy
Hospital Universitario De Canarias La Laguna Spain
Polyclinique Bordeaux Nord Aquitaine Bordeaux France
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy Bydgoszcz Poland
St. Vincenz-Krankenhaus GmbH Paderborn Germany
Universitair Ziekenhuis Gent Gent Belgium
Universitaetsklinikum Aachen AöR Aachen Germany
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario 12 De Octubre Madrid Spain
Hospital San Pedro De Alcantara Caceres Spain
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur Namur Belgium
Institut Sainte Catherine Avignon France
Mruk-Med I Sp. z o.o. Rzeszow Poland
Praxis Fuer Interdisziplinaere Onkologie And Haematologie GbR Freiburg Im Breisgau Germany
Mammazentrum Hamburg MVZ GbR Hamburg Germany
Brustzentrum Rhein-Ruhr Servicegesellschaft mbH Moenchengladbach Germany
Centre De Lutte Contre Le Cancer Eugene Marquis Rennes France
Chqhuxwuq Uuevxfjvgsdgbq Sslamztwr Woluwe-Saint-Lambert Belgium
Ikfztwwn Rrraqqrc Dr Cjpxgt Dn Mwuwrmzeymn Montpellier France
Pqjexskpnaf Lltjoqzz &asumufgdjsloccssbsw Rpppv Kytcigqbmho Konin Poland
Ioxekydn Rtlkkjegj Psh Lb Sdcsrl Dvw Tunjqx Dawz Alqcjcs Iyfh Slsxyh Meldola Italy
Ccseav Lnvp Bpvluu Lyon France
Urydjlxjzq Oa Aepipef Edegem Belgium
Umgizmvyjbdbbroomttat Efnwn Aml Essen Germany
Inbabnxz Cgbomj Dezhpczkzqoyqzkwp L'hospitalet De Llobregat Spain
Spqyefcw Pekzelnhz Sqw z okas Gdynia Poland
Hldwsvhk Vbra dpnrbmwd Barcelona Spain

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
29.06.2023
France France
Not recruiting
29.06.2023
Germany Germany
Not recruiting
29.06.2023
Italy Italy
Not recruiting
29.06.2023
Poland Poland
Not recruiting
29.06.2023
Spain Spain
Not recruiting
29.06.2023

Trial locations

Inavolisib is a new investigational medication that targets specific mutations in breast cancer cells. It belongs to a class of drugs that work by blocking certain proteins involved in cancer cell growth. It is given in combination with fulvestrant to treat advanced breast cancer.

Fulvestrant is a hormone therapy medication that blocks the effects of estrogen on cancer cells. It is commonly used to treat hormone receptor-positive breast cancer in postmenopausal women whose disease has progressed after other hormone treatments.

Alpelisib is a targeted therapy medication that blocks specific proteins involved in cancer cell growth. Like inavolisib, it is used in combination with fulvestrant to treat certain types of advanced breast cancer that have specific genetic mutations.

CDK4/6 inhibitors are a class of medications that work by blocking specific proteins involved in cell division. These medications are typically used in combination with hormone therapy to treat hormone receptor-positive breast cancer.

Metastatic Breast Cancer – A form of breast cancer that has spread beyond the breast and nearby lymph nodes to other parts of the body, most commonly to the bones, liver, lungs, or brain. The cancer cells break away from the original tumor and travel through the bloodstream or lymphatic system to form new tumors in other organs. The disease develops when breast cancer cells gain the ability to detach from the primary tumor and establish growth in distant locations. The progression of metastatic breast cancer can vary significantly among individuals. The condition is characterized by the presence of breast cancer cells in organs distant from the breast tissue.

Trial ID:
2022-502322-41-00
Protocol code:
WO43919
Trial Phase:
Therapeutic confirmatory (Phase III)

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