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PI3K Inhibitor

Alpelisib + Endocrine Therapy for Breast Cancer

Phase 2
Recruiting
Led By Amanda Parkes, MD
Research Sponsored by Amanda Parkes
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Premenopausal females must agree to use an acceptable method of contraception or to abstain from sexual intercourse for the duration of their participation in the study and for 3 months after discontinuation of therapy. Adequate forms of contraception include: total abstinence, surgery intended to prevent pregnancy (defined as hysterectomy, bilateral oophorectomy or bilateral tubal ligation), non-hormonal IUD, or condom/occlusive cap with spermicidal foam/gel/film/cream/suppository).
Men and postmenopausal female patients. Premenopausal patients (age 18 or older) who have been rendered postmenopausal will also be included. Postmenopausal is defined as: Age >= 55 years and one year or more of amenorrhea. Age < 55 years and one year or more of amenorrhea, with estradiol < 20 pg/ml. Age < 55 years with prior hysterectomy but intact ovaries, with estradiol < 20 pg/ml. Prior bilateral oophorectomy. NOTE: Women who do not fit the criteria for being postmenopausal as above are deemed premenopausal. Premenopausal patients (age 18 or older) who can be rendered postmenopausal will also be eligible. Methods eligible for rending premenopausal patients postmenopausal include: Ongoing treatment with luteinizing hormone-releasing hormone (LHRH) agonist, with treatment starting at least 4 weeks prior to randomization and with estradiol < 20 pg/ml. LHRH agonist must be administered within 7 days of scheduled administration date during the length of the clinical trial.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment until the time of death, up to 60 months
Awards & highlights

Study Summary

This trial is for patients with late-stage breast cancer who have a specific genetic mutation. They will take a daily drug (alpelisib) in combination with a standard cancer treatment. The trial will follow patients to see how well they respond to the new drug.

Who is the study for?
This trial is for adults with hormone receptor positive, HER2 negative, PIK3CA mutant metastatic breast cancer that has progressed after endocrine therapy. Participants must have an ECOG Performance Status of 0-2 and adequate organ function. Men and premenopausal women must agree to contraception. Exclusions include prior chemotherapy for advanced disease, other malignancies, CNS metastases causing symptoms, uncontrolled diseases or infections.Check my eligibility
What is being tested?
The study tests alpelisib in combination with ongoing endocrine therapy (Fulvestrant or Aromatase Inhibitor) in patients whose breast cancer has worsened on just endocrine therapy. It's a multi-phase trial including screening, treatment until disease progression/toxicity, and post-treatment follow-up to assess safety and effectiveness.See study design
What are the potential side effects?
Alpelisib can cause high blood sugar levels which may need medical attention. Other side effects might include rash, nausea, fatigue and diarrhea. Fulvestrant may cause injection site reactions while aromatase inhibitors can lead to bone loss or joint pain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I agree to use effective birth control or abstain from sex during and 3 months after the study.
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I am a man, or I am a woman who is postmenopausal or have been made postmenopausal.
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I have been mostly active and able to care for myself in the last 28 days.
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I have been treated with a CDK4/6 inhibitor for breast cancer that has spread.
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I am 18 years old or older.
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I will use approved birth control methods if I'm not sterile.
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I understand and can follow the study's procedures.
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I have a tumor that can be measured or a specific type of bone lesion.
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My organ functions are within normal ranges as required.
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My last cancer treatment was hormone therapy, but my cancer still progressed.
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My cancer has a PIK3CA mutation.
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My cancer is hormone receptor positive with ER and/or PR levels at or above 1%.
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My breast cancer is confirmed to be HER2 negative.
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My breast cancer cannot be removed by surgery and has spread.
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I have been treated with hormone therapy for my cancer that has spread.
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I have had 2 or fewer hormone treatments for my cancer that has spread.
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I am HIV-positive, on effective treatment, and my viral load has been undetectable for the last 6 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment until the time of death, up to 60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment until the time of death, up to 60 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-Free Survival (PFS)
Secondary outcome measures
Clinical Benefit Rate (CBR)
Duration of Response (DOR)
Objective Response Rate (ORR)
+2 more

Side effects data

From 2023 Phase 3 trial • 572 Patients • NCT02437318
62%
Hyperglycaemia
57%
Diarrhoea
45%
Nausea
35%
Rash
35%
Decreased appetite
26%
Vomiting
26%
Weight decreased
24%
Fatigue
24%
Stomatitis
20%
Asthenia
20%
Alopecia
18%
Mucosal inflammation
18%
Pruritus
17%
Dysgeusia
17%
Headache
15%
Dry skin
14%
Oedema peripheral
14%
Pyrexia
14%
Back pain
13%
Rash maculo-papular
11%
Dyspepsia
11%
Abdominal pain
11%
Arthralgia
10%
Urinary tract infection
10%
Blood creatinine increased
10%
Gamma-glutamyltransferase increased
10%
Dry mouth
10%
Aspartate aminotransferase increased
10%
Cough
8%
Dizziness
8%
Hypertension
8%
Pain in extremity
8%
Anaemia
8%
Constipation
8%
Nasopharyngitis
8%
Alanine aminotransferase increased
8%
Hypokalaemia
8%
Dyspnoea
7%
Myalgia
7%
Muscle spasms
7%
Insomnia
6%
Lipase increased
6%
Abdominal pain upper
5%
Lymphoedema
5%
Musculoskeletal pain
5%
Erythema
4%
Upper respiratory tract infection
4%
Bone pain
3%
Hot flush
2%
Osteonecrosis of jaw
2%
Acute kidney injury
1%
Upper gastrointestinal haemorrhage
1%
General physical health deterioration
1%
Dehydration
1%
Pleural effusion
1%
Pneumonitis
1%
Cellulitis
1%
Pulmonary embolism
1%
Hypersensitivity
1%
Pneumonia
1%
Hyponatraemia
1%
Muscular weakness
1%
Brain oedema
1%
Renal failure
1%
Erythema multiforme
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo qd + Fulvestrant
Alpelisib qd + Fulvestrant

Trial Design

1Treatment groups
Experimental Treatment
Group I: Alpelisib + Aromatase Inhibitor or FulvestrantExperimental Treatment3 Interventions
Subjects will be treated with Alpelisib in combination with either an Aromatase Inhibitor or Fulvestrant per Standard of Care
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Alpelisib
2018
Completed Phase 3
~900
Fulvestrant
2011
Completed Phase 3
~3700
Aromatase inhibitor
2011
Completed Phase 4
~2620

Find a Location

Who is running the clinical trial?

Amanda ParkesLead Sponsor
Marina N SharifiLead Sponsor
NovartisIndustry Sponsor
1,609 Previous Clinical Trials
2,717,882 Total Patients Enrolled
57 Trials studying Breast Cancer
21,188 Patients Enrolled for Breast Cancer

Media Library

Alpelisib (PI3K Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04762979 — Phase 2
Breast Cancer Research Study Groups: Alpelisib + Aromatase Inhibitor or Fulvestrant
Breast Cancer Clinical Trial 2023: Alpelisib Highlights & Side Effects. Trial Name: NCT04762979 — Phase 2
Alpelisib (PI3K Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04762979 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Alpelisib a proven therapy, as evidenced by past experiments?

"Presently, Alpelisib is the focus of 152 active studies with 35 in Phase 3. While Shanghai has a large number of trials involving this compound, it can be accessed at 6490 different medical centres around the world."

Answered by AI

Does this research endeavor still have room for participants?

"According to clinicaltrials.gov, this ongoing medical study is currently recruiting subjects. Initially posted on February 12th 2021, the trial's details were most recently reviewed and updated on November 14th 2022."

Answered by AI

Could you shed some light on the potential risks of taking Alpelisib?

"The safety of Alpelisib was assessed as a 2 due to its current standing in Phase 2 clinical trials, with evidence indicating that it is safe but no data currently affirming its efficacy."

Answered by AI

What is the cap for enrollment in this clinical trial?

"Novartis requires 44 individuals that meet their criteria in order to run this trial. The pharmaceutical company will be hosting the study from two locations, University of Illinois Cancer Center (Chicago) and Penn State Cancer Institute (Hershey)."

Answered by AI

What medical conditions has Alpelisib been successful in treating?

"Alpelisib is commonly employed as a response to endocrine therapy. It has also demonstrated efficacy in treating multiple other maladies such as disease, breast cancer, and pik3ca gene mutation."

Answered by AI
~11 spots leftby Mar 2025