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Monoclonal Antibodies
Taselisib + Anti-HER2 Therapies for Breast Cancer
Phase 1
Waitlist Available
Led By Ian Krop, MD
Research Sponsored by Otto Metzger, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing a new drug, Taselisib, to see if it can help treat metastatic breast cancer. Taselisib works by blocking a protein that helps cancer cells grow. The goal is to find the best dose of Taselisib to use with other drugs in future studies.
Who is the study for?
This trial is for adults with advanced HER2+ breast cancer, who've had treatments like trastuzumab but not Taselisib or BYL-719. They should have acceptable blood counts, organ function, and no major surgery within the last month. Women must test negative for pregnancy and agree to contraception; men also need to use barrier protection.Check my eligibility
What is being tested?
The study tests different doses of Taselisib combined with anti-HER2 therapies (like Paclitaxel, Pertuzumab) in four separate groups to find the safest and most effective dose. It's an early-phase trial where everyone gets some form of treatment combination.See study design
What are the potential side effects?
Taselisib may cause high blood sugar levels, diarrhea, skin rash, liver enzyme changes, fatigue and nausea. Other drugs used can add side effects like allergic reactions or heart issues related to infusion.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum Tolerated Dose (MTD) of Taselisib in combination with anti-HER2 therapy(ies) and/or paclitaxel.
Secondary outcome measures
Clinical Benefit Rate (CBR) for efficacy of Taselisib in combination with anti-HER2 therapy(ies) and/or paclitaxel.
Dose Limiting Toxicity of Taselisib in combination with anti-HER2 therapy(ies) and/or paclitaxel.
Occurrence of AEs and SAEs during treatment with Taselisib in combination with anti-HER2 therapy(ies) and/or paclitaxel.
+4 moreSide effects data
From 2017 Phase 2 trial • 334 Patients • NCT0227397329%
Diarrhoea
21%
Nausea
20%
Fatigue
16%
Hyperglycaemia
15%
Hot flush
13%
Stomatitis
11%
Arthralgia
10%
Asthenia
10%
Headache
9%
Rash
8%
Alopecia
7%
Decreased appetite
6%
Dry skin
6%
Constipation
6%
Vomiting
6%
Hypertension
5%
Alanine aminotransferase increased
5%
Dizziness
5%
Cough
5%
Dyspepsia
4%
Dry mouth
4%
Viral upper respiratory tract infection
4%
Urinary tract infection
4%
Back pain
4%
Insomnia
4%
Pruritus
1%
Erysipelas
1%
Enterocolitis haemorrhagic
1%
Sudden death
1%
Erythema multiforme
1%
Dehydration
1%
Pneumonitis
1%
Bacterial diarrhoea
1%
Cytomegalovirus infection
1%
Diarrhoea infectious
1%
Gastroenteritis
1%
Pneumonia
1%
Colitis
1%
Enterocolitis
1%
Impaired healing
1%
Postoperative wound infection
1%
Memory impairment
100%
80%
60%
40%
20%
0%
Study treatment Arm
Experimental: Taselisib + Letrozole
Placebo Comparator: Placebo + Letrozole
Trial Design
4Treatment groups
Experimental Treatment
Group I: Arm DExperimental Treatment4 Interventions
Arm D
Taselisib with Pertuzumab, Trastuzumab, and Paclitaxel
Cohort will not be opened without additional authorization from Genentech
Taselisib- administered oral, daily in each treatment cycle (3 weeks).
Pertuzumab- administered once via IV per treatment cycle (3 weeks).
Trastuzumab administered once via IV per treatment cycle (3 weeks).
Paclitaxel- administered via IV, weekly for 3 weeks within each cycle.
Group II: Arm CExperimental Treatment3 Interventions
Arm C:
Taselisib with Pertuzumab and Trastuzumab
Cohort C will not open without additional authorization from Genentech
Taselisib is administered oral, daily in each treatment cycle (3 weeks).
Trastuzumab administered once via IV per treatment cycle (3 weeks).
Pertuzumab- administered once via IV per treatment cycle (3 weeks).
Group III: Arm BExperimental Treatment3 Interventions
Arm B
-Taselisib with T-DM1 and Pertuzumab
Taselisib is administered oral, daily or every other day per treatment cycle (3 weeks).
Trastuzumab emtansine (also called T-DM1) administered once via IV per treatment cycle (3 weeks).
Pertuzumab- administered once via IV per treatment cycle (3 weeks).
Group IV: Arm AExperimental Treatment2 Interventions
Arm A
- Taselisib with Trastuzumab emtansine (also called T-DM1)
Taselisib administered orally, daily in each treatment cycle (3 weeks).
Trastuzumab emtansine (also called T-DM1) administered once via IV per treatment cycle (3 weeks).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
2011
Completed Phase 4
~5380
Taselisib
2014
Completed Phase 2
~2230
Pertuzumab
2014
Completed Phase 3
~7500
Trastuzumab emtansine
2010
Completed Phase 4
~2220
Trastuzumab
2014
Completed Phase 4
~5190
Find a Location
Who is running the clinical trial?
Otto Metzger, MDLead Sponsor
Dana-Farber Cancer InstituteLead Sponsor
1,078 Previous Clinical Trials
340,804 Total Patients Enrolled
142 Trials studying Breast Cancer
22,617 Patients Enrolled for Breast Cancer
Genentech, Inc.Industry Sponsor
1,539 Previous Clinical Trials
567,621 Total Patients Enrolled
97 Trials studying Breast Cancer
23,218 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a significant history of liver problems.I experience significant numbness or pain in my hands or feet.I do not need medication to control seizures.I haven't had major surgery in the last 4 weeks.I do not have conditions that affect how my body absorbs food.I haven't had cancer treatment in the last 2 weeks and have recovered from any previous treatments.I don't have untreated brain metastases but may have had treated ones.I have not had a major injury in the last 3 weeks.My cancer has spread outside the brain and spinal cord.My brain cancer has not worsened after my last treatment.I have never had bleeding in my brain or spinal cord.You have had allergic reactions or hypersensitivity to similar drugs or substances used in this study.I take medication for my type 1 or type 2 diabetes.I have needed frequent fluid removal from my abdomen weekly for the last 2 weeks.I am HIV positive.I need daily extra oxygen.I need ongoing treatment for high calcium levels in my blood.I agree to use a condom and ensure my partner uses contraception during and for 7 months after the trial.You cannot or do not want to swallow pills.I have had treatments like trastuzumab but not Taselisib or BYL-719.My breast cancer has spread or come back locally.I am a woman who can have children and have a recent negative pregnancy test.I am willing to have a biopsy for research and understand I won't need a repeat if the first attempt fails.I had a severe reaction to cancer drugs targeting PI3K, AKT, or mTOR.I do not have any other major health issues that would interfere with the study.It's been over 3 weeks since my brain radiotherapy, and I've recovered from major side effects without needing steroids.I am using effective birth control or practicing abstinence.I will use effective birth control during and for 7 months after my treatment.My cancer has spread to the lining of my brain and spinal cord only.I have a long QT syndrome or my QTc is over 500 msec.I am taking medication that affects how my body processes drugs.I have active inflammation in my intestines, like Crohn's disease or ulcerative colitis.I have heart issues that need medication.My magnesium, potassium, or calcium levels are low despite treatment.My breast cancer is confirmed to be HER2 positive.I am fully active or can carry out light work.My blood tests for organ and bone marrow function are normal.My kidney function is within the normal range.I am currently on IV antibiotics for an infection.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B
- Group 2: Arm D
- Group 3: Arm A
- Group 4: Arm C
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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