Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

All Drugs and Chemicals

Antineoplastic Agents

Reproductive Control Agents

Hormones

Fulvestrant

Leuprolide

Goserelin

Triptorelin Pamoate

Antineoplastic Agents, Hormonal

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormone Antagonists

Oral alpelisib (300 mg daily, in 28-day cycle) and fulvestrant as per standard practice. Moreover, men and premenopausal women will receive an LH-RH analogue (goserelin, leuprorelin, or triptorelin) every 28 days ±3 days, as per standard practice

Oral ribociclib (600 mg daily, 3 weeks on, then 1 week off treatment in 28-day cycles) and fulvestrant as per standard practice. Moreover, men and premenopausal women will receive an LH-RH analogue (goserelin, leuprorelin, or triptorelin) every 28 days ±3 days, as per standard practice.

Alpelisib 300 mg once daily + fulvestrant 500 mg every 28 days

Alpelisib

Ribocilcib 600 mg once daily 3 weeks on/1 week off + fulvestrant 500 mg every 28 days

Ribociclib

Fabrice ANDRE

François LEGRAND

Aurélie MOREIRA, Dr

Khadija KALAI, Dr

Adina MARTI, Dr

Bertrand BILLEMONT, Dr

Hanifa AMMARGUELLAT, Dr

Olivier ARSENE, Dr

Monica ARNEDOS, Dr

Abeer NAJEM, Dr

Laura DEIANA, Dr

Brigitte LUCAS, Dr

George EMILE, Dr

Rolande NGUEFACK, Dr

Thomas COLLOT, Dr

Victor SIMMET, Dr

Lionel MOREAU, Dr

Xavier DURANDO, Pr

Mansour RASTKHAH, Dr

Jean-François PAITEL, Dr

Elise BONNET, Dr

Céline BIHAN, Dr

Sophie BARTHIER, Dr

Dominique GENET, Dr

Thomas BACHELOT, Dr

Olfa DERBEL MILED, Dr

Yann MOLIN, Dr

Anthony GONCALVES, Pr

William JACOT, Pr

Laurene GAVOILLE, Dr

Jean-Michel VANNETZEL, Dr

Caroline BAILLEUX, Dr

Luis TEIXEIRA, Pr

Catherine DELBALDO, Dr

Kévin BOURCIER, Dr

Jérôme MARTIN-BABAU, Dr

Pauline SOIBINET-OUDOT, Dr

Fanny LE DU, Dr

Romuald LE SCODAN, Dr

Youssef TAZI, Dr

Fanny POMMERET, Dr

Florence DALENC, Dr

Vincent MASSARD, Dr

Joana MOURATO-RIBEIRO, Dr

After an initial screening phase (SAFIR 03 - SCREENING) to identify patients with blood circulating mutated-PIK3CA tumours persistent, patients will be enrolled in the treatment phase of SAFIR 03 (SAFIR 03 - ARRIBA) that was designed as a randomised, open-label, multicentre, phase II study, for comparison of alpelisib to ribociclib in combination with fulvestrant (as the continuation of the CDK4/6 inhibitor-fulvestrant strategy) in terms of progression-free survival (PFS).

INDICATION The population eligible to the screening phase is composed of all women or men with HR+, HER2- metastatic breast cancer who are eligible for first-line treatment with a cyclin-dependent kinases (CDK) 4/6 inhibitor combined with fulvestrant (and a luteinizing hormone realeasing hormone (LH-RH) analogue in men and premenopausal women) in the context of the standard healthcare management. The screening will identify patients with high risk of relapse on any CDK4/6 inhibitor thanks to ctDNA kinetic between baseline and 4 weeks of treatment. The purpose is to early adapt the therapeutic intervention for ctDNA no drop patient to prevent from relapse. This study will propose an intervention for PIK3CA mutated patients with alpelisib vs. ribociclib. Other therapeutic approaches might be proposed to patients with wild type PIK3CA through other protocols.

The randomised study phase will include patients with persistent mutations on exons 4, 9 or 20\* of PIK3CA ctDNA after 4 weeks of treatment with any CDK4/6 inhibitor-fulvestrant in first-line setting.

After an initial screening phase (SAFIR 03 - SCREENING) to identify patients with blood circulating mutated-PIK3CA tumours persistent, patients will be enrolled in the treatment phase of SAFIR 03 (SAFIR 03 - ARRIBA) that was designed as a randomised, open-label, multicentre, phase II study, for comparison of alpelisib to ribociclib in combination with fulvestrant (as the continuation of the CDK4/6 inhibitor-fulvestrant strategy)

Detection of Tumor DNA in the Blood of Patients Receiving Standard Therapy for Hormone Receptor-positive (HR+) Non-HER2 Expressing (HER2-) Metastatic Breast Cancer as a Tool to Select Those Who May Benefit From the Next Course of Fulvestrant in Combination With Alpelisib or Ribociclib

A ctDNA Screening Program in Patients With HR+, HER2- Metastatic Breast Cancer for Detection of High-risk Relapse Patients on Any CDK4/6 Inhibitor and a Randomised Phase II Study Comparing Alpelisib Combined With Fulvestrant to Ribociclib Combined With Fulvestrant, in Patients With Persistent Targetable PIK3CA Mutations

The PFS is the length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse.

Overall survival (OS) is the length of time from randomization that patients enrolled in the study are still alive.

Objective response rate (ORR) is the percentage of patients with a best response during treatment being either complete response (CR) or partial response (PR).

Duration of response (DoR) is defined as the time interval from the date of first documented CR or PR to the date of first documented disease progression or death, from any cause.

Clinical benefit rate (CBR) is defined as the proportion of patients with a best overall response of CR, PR, or stable disease during treatment.

Time to response (TTR) is defined, for subjects with an objective response (OR), as the time from randomisation to the first documentation of OR which is subsequently confirmed.

For this outcome, PFS is defined as the time interval between the date of initiation of standard of care to the date of the first documented disease progression or death, whatever the cause.

The National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5) is widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale, divided into 5 grades (1 = "mild", 2 = "moderate", 3 = "severe", 4 = "life-threatening", and 5 = "death") determined by the investigator, will make it possible to assess the severity of the disorders.

For non-randomised patients, OS is the length of time from the date of initiation of standard of care that patients enrolled in the study are still alive.

For non-randomised patients, PFS is the length of time during and after the treatment of a disease with the standard of care that a patient lives with the disease but it does not get worse.

Novartis

Breast Cancer Research Foundation

UNICANCER

Spots Global Cancer Trial Database for rh+

Every month we try and update this database with for rh+ cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for rh+

Every month we try and update this database with for rh+ cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for rh+ cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.