Study: NCT04300790

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Alpelisib
Description: Alpelisib (BYL719): starting dose at 300 mg/QD.; 2 tablets once a day, oral administration, continuously during 28-day cycles until disease progression or unacceptable toxicity.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Alpelisib
Description: Alpelisib (BYL719): starting dose at 300 mg/QD.; 2 tablets once a day, oral administration, continuously during 28-day cycles until disease progression or unacceptable toxicity.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Alpelisib
Description: Alpelisib (BYL719): starting dose at 300 mg/QD.; 2 tablets once a day, oral administration, continuously during 28-day cycles until disease progression or unacceptable toxicity.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Metformin
Description: 500 mg BID with breakfast and dinner. After 3 days, if no (GI) intolerance, increase to 1000 mg BID with breakfast and dinner. If not tolerated, reduce to prior tolerated dose. Titrate to 1000mg BID over a period of at least 4 additional days

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Metformin
Description: 500 mg BID with breakfast and dinner. After 3 days, if no (GI) intolerance, increase to 1000 mg BID with breakfast and dinner. If not tolerated, reduce to prior tolerated dose. Titrate to 1000mg BID over a period of at least 4 additional days

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Metformin
Description: 500 mg BID with breakfast and dinner. After 3 days, if no (GI) intolerance, increase to 1000 mg BID with breakfast and dinner. If not tolerated, reduce to prior tolerated dose. Titrate to 1000mg BID over a period of at least 4 additional days

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Fulvestrant
Description: fulvestrant (500 mg IM injections; loading dose 500mg every two weeks for the first month; then every 4 weeks as per standard of care \[SoC\].~Patients should be started on metformin and fulvestrant within 7 to 14 days prior to start on alpelisib (D1C1)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Fulvestrant
Description: fulvestrant (500 mg IM injections; loading dose 500mg every two weeks for the first month; then every 4 weeks as per standard of care \[SoC\].~Patients should be started on metformin and fulvestrant within 7 to 14 days prior to start on alpelisib (D1C1)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Fulvestrant
Description: fulvestrant (500 mg IM injections; loading dose 500mg every two weeks for the first month; then every 4 weeks as per standard of care \[SoC\].~Patients should be started on metformin and fulvestrant within 7 to 14 days prior to start on alpelisib (D1C1)

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Letrozole
Description: Letrozole 2.5 mg tablets, once daily, orally

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Letrozole
Description: Letrozole 2.5 mg tablets, once daily, orally

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Letrozole
Description: Letrozole 2.5 mg tablets, once daily, orally

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Exemestane
Description: Exemestane 25 mg tablets, once daily, orally

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Exemestane
Description: Exemestane 25 mg tablets, once daily, orally

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Exemestane
Description: Exemestane 25 mg tablets, once daily, orally