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alpelisib for Breast Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Novartis Investigative Site, Rosario, ArgentinaBreast Canceralpelisib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new cancer drug to see if it's safe and effective for treating advanced triple negative breast cancer in patients with either a PIK3CA mutation or PTEN loss.

Eligible Conditions
  • Triple Negative Breast Cancer

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Similar Trials

1
iNOS inhibitor and nab-paclitaxel in combination with alpelisib.
1
REGN7075
1
Alpelisib

Study Objectives

3 Primary · 28 Secondary · Reporting Duration: Once approximately 192 PFS events in Study Part B2 had been observed, up to 22 months

Month 35
Progression-free Survival (PFS) Per Investigator Assessment in Study part A
Month 22
Progression-free Survival (PFS) Per Investigator Assessment in Study part B2
Up to 22 months
Change from baseline in the global health status/QoL scale score of the EORTC QLQ-C30 in study Part B2
Clinical benefit rate (CBR) with confirmed response in Study Part B2
Duration of Response (DOR) with confirmed response in Study Part B2
Overall response rate (ORR) with confirmed response in Study Part B2
PFS based on local radiology assessments using RECIST 1.1 criteria for subjects by PIK3CA mutation status measured in baseline ctDNA in study Part B2
Time to 10% definitive deterioration in the global health status/QOL scale score of the EORTC QLQ-C30 in study Part B2
Time to definitive deterioration of the ECOG performance status from baseline in Study Part B2
Time to response (TTR) in Study Part B2
Up to 35 months
Change from baseline in the global health status/Quality of life (QoL) scale score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item Core Module (EORTC QLQ-C30) in study Part A
Clinical benefit rate (CBR) with confirmed response in Study Part A
Duration of Response (DOR) with confirmed response in Study Part A
Heart rate
PFS based on local radiology assessments using RECIST 1.1 criteria for subjects by PIK3CA mutation status measured in baseline ctDNA in study Part A
Plasma concentrations of alpelisib - Part A
Plasma
Time to 10% definitive deterioration in the global health status/QOL scale score of the EORTC QLQ-C30 in study Part A
Time to definitive deterioration of the Eastern Cooperative Oncology Group (ECOG) performance status (PS) from baseline in Study Part A
Time to response (TTR) in Study Part A
Up to 41 months
Overall Survival (OS) in Study Part B2
Up to 6 months
Clinical benefit rate (CBR) with confirmed response in Study Part B1
Duration of Response (DOR) with confirmed response in Study Part B1
Overall Response Rate (ORR) based on local radiology assessments in subjects with measurable disease at baseline in study Part B1
Overall Survival (OS) in Study Part B1
Plasma concentrations of alpelisib - Part B1
Progression-free Survival (PFS) Per Investigator Assessment in Study part B1
Time to response (TTR) in Study Part B1
Up to 66 months
Overall Survival (OS) in Study Part A
up to 22 months
Plasma concentrations of alpelisib -Part B2
up to 6 months
Plasma concentrations of paclitaxel - Part B1

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

2
iNOS inhibitor and nab-paclitaxel in combination with alpelisib.
1
REGN7075
2
Alpelisib

Side Effects for

Buparlisib + Letrozole
60%Alanine aminotransferase increased
54%Aspartate aminotransferase increased
47%Hyperglycaemia
46%Nausea
38%Rash
37%Fatigue
36%Diarrhoea
31%Decreased appetite
27%Dizziness
22%Pruritus
22%Stomatitis
20%Asthenia
20%Anxiety
17%Dry skin
16%Arthralgia
15%Depression
15%Hot flush
14%Dysgeusia
14%Dyspepsia
12%Weight decreased
12%Headache
12%Hypertension
11%Rash maculo-papular
10%Tremor
10%Insomnia
10%Cough
10%Breast pain
10%Chills
9%Urinary tract infection
9%Abdominal pain upper
9%Constipation
9%Back pain
7%Vomiting
7%Blood bilirubin increased
7%Gamma-glutamyltransferase increased
7%Abdominal distension
6%Memory impairment
6%Viral upper respiratory tract infection
6%Procedural pain
6%Tachycardia
6%Vertigo
6%Abdominal pain
6%Dry mouth
6%Muscle spasms
5%Oedema peripheral
5%Musculoskeletal pain
5%Myalgia
4%Alopecia
4%Blood glucose increased
4%Hepatotoxicity
4%Vision blurred
2%Colitis
2%Paraesthesia
2%Mucosal dryness
2%Atrial fibrillation
1%Iritis
1%Epistaxis
1%Syncope
1%Pyrexia
1%Skin necrosis
1%Blood creatinine increased
1%Post procedural haematoma
1%Cardiac disorder
1%General physical health deterioration
1%Generalised oedema
1%Malaise
1%Hypertransaminasaemia
1%Sepsis
1%Angioedema
1%Hypokalaemia
This histogram enumerates side effects from a completed 2017 Phase 2 trial (NCT01923168) in the Buparlisib + Letrozole ARM group. Side effects include: Alanine aminotransferase increased with 60%, Aspartate aminotransferase increased with 54%, Hyperglycaemia with 47%, Nausea with 46%, Rash with 38%.

Trial Design

2 Treatment Groups

alpelisib + nab-paclitaxel
1 of 2
placebo + nab-paclitaxel
1 of 2

Experimental Treatment

Non-Treatment Group

137 Total Participants · 2 Treatment Groups

Primary Treatment: alpelisib · Has Placebo Group · Phase 3

alpelisib + nab-paclitaxelExperimental Group · 2 Interventions: nab-paclitaxel, alpelisib · Intervention Types: Drug, Drug
placebo + nab-paclitaxelPlaceboComparator Group · 2 Interventions: nab-paclitaxel, placebo · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
FDA approved
Alpelisib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: once approximately 192 pfs events in study part b2 had been observed, up to 22 months

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,738 Previous Clinical Trials
3,544,077 Total Patients Enrolled
81 Trials studying Breast Cancer
30,399 Patients Enrolled for Breast Cancer

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have been treated for metastatic disease only once before.
Your bones and organs are healthy and working properly.

Who else is applying?

What state do they live in?
Virginia100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Florida Cancer Specialists Dept of Oncology (2)100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

How responsive is this trial?

Most responsive sites:
  1. Florida Cancer Specialists Dept of Oncology (2): < 48 hours
Average response time
  • < 2 Days
Typically responds via
Email100.0%
References

Frequently Asked Questions

In how many different locations can patients participate in this study?

"There are 35 sites operating for this study, including Mayo Clinic Arizona in Phoenix, Renown Healthcare Systems in Reno, and Chattanooga Oncology and Hematology Associates PC Tennessee Oncology Chattanooga in Chattanooga." - Anonymous Online Contributor

Unverified Answer

Are there other examples of research done on alpelisib?

"There are hundreds of ongoing studies related to alpelisib, with many in Phase 3. Alpelisib trials can be found at several hundred locations around the world." - Anonymous Online Contributor

Unverified Answer

What are the goals that this experiment is looking to achieve?

"The primary goal of this study, which will be measured over the course of approximately 22 months, is to observe the Progression-free Survival (PFS) of patients according to investigator assessment. Once 192 PFS events have been observed in Study Part B2, secondary objectives including Overall response rate (ORR), change from baseline in Quality of Life (QoL), and Time to Response (TTR) will also be monitored." - Anonymous Online Contributor

Unverified Answer

How many patients are being observed in this clinical trial?

"To successfully run this trial, 566 patients that meet the inclusion criteria are needed. The sponsor of the trial, Novartis Pharmaceuticals, will be carrying out the study at multiple locations; for example, Mayo Clinic Arizona in Phoenix and Renown Healthcare Systems located in Reno." - Anonymous Online Contributor

Unverified Answer

When might alpelisib gain official sanction from the FDA?

"There is both preclinical and clinical evidence for alpelisib's efficacy, so it received a score of 3." - Anonymous Online Contributor

Unverified Answer

For what reason is alpelisib most often prescribed?

"While most commonly used to treat neoplasm metastasis, alpelisib can also help patients with kaposi sarcoma, fallopian tubes cancer, and other conditions related to advance directives." - Anonymous Online Contributor

Unverified Answer

Are there still open positions available in this clinical trial for test subjects?

"Yes, that is accurate. The public information available on clinicaltrials.gov shows that this trial was posted on 6/8/2020 and updated as recently as 10/21/2022. 566 patients are needed for the study, which is taking place at 35 different locations." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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