Inavolisib for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Hospital Clinico Universitario de Valencia, Valencia, Spain
Breast Cancer+2 More
Inavolisib - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug may help treat breast cancer.

See full description

Eligible Conditions

  • Breast Cancer
  • Tumors, Solid

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Inavolisib will improve 3 primary outcomes and 23 secondary outcomes in patients with Breast Cancer. Measurement will happen over the course of Baseline, Week 2.

Year 6
Percentage of Participants With Clinical Benefit as Assessed by RECIST v1.1
Progression Free Survival (PFS) as Assessed by RECIST v1.1
Year 6
Percentage of Participants With Objective Response as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 (v1.1)
Baseline, Week 2
Change in Maximum Standard Uptake Value (SUV) of Tumor Regions of Interest (as assessed by [18] F-fluorodeoxyglucose-positron emission tomography) From Baseline to Approximately 2 Weeks of Inavolisib Treatment
Year 6
Percentage of Participants With Adverse Events and Serious Adverse Events
Day 35
Recommended Phase II Dose of Inavolisib
Stage 1: Percentage of Participants With Dose Limiting Toxicities
Year 6
Duration of Response, as Assessed by RECIST v1.1
Year 6
AUC from Time Zero to Dosing Interval (AUC0-tau) of Inavolisib
Accumulation Ratio (AR) of Inavolisib at Steady-State
Apparent Clearance (CL/F) of Inavolisib
Half-Life of Inavolisib
Maximum Plasma Concentration (Cmax) of Inavolisib
Minimum Plasma Concentration (Cmin) of Inavolisib
Time to Cmax (tmax) of Inavolisib
Year 6
Area Under the Concentration Time-Curve (AUC) from Time Zero to Infinity (AUCinf) of Inavolisib
Year 6
AUC of Pertuzumab
AUC of Trastuzumab
Cmax of Pertuzumab
Cmax of Trastuzumab
Year 6
AUC of Fulvestrant
AUC of Letrozole
Cmax of Fulvestrant
Cmax of Letrozole
Day 28
AUC of Palbociclib
Cmax of Palbociclib

Trial Safety

Safety Progress

1 of 3

Trial Design

9 Treatment Groups

Stage I Arm B: Inavolisib + Palbociclib + Letrozole
1 of 9
Stage II Arm C: Inavolisib + Letrozole
1 of 9
Stage II Arm F: Inavolisib + Palbociclib + Fulvestrant + Metformin
1 of 9
Stage II Arm D: Inavolisib + Fulvestrant
1 of 9
Stage II Arm G: Inavolisib + Trastuzumab + Pertuzumab
1 of 9
Stage I Arm A: Inavolisib Single Agent
1 of 9
Stage II Arm E: Inavolisib + Palbociclib + Fulvestrant
1 of 9
Stage II Arm B: Inavolisib + Palbociclib + Letrozole
1 of 9
Stage I Arm C: Inavolisib + Letrozole
1 of 9
Experimental Treatment

This trial requires 256 total participants across 9 different treatment groups

This trial involves 9 different treatments. Inavolisib is the primary treatment being studied. Participants will be divided into 9 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Stage I Arm B: Inavolisib + Palbociclib + LetrozoleParticipants will receive inavolisib in escalating dose levels (starting dose 3 mg) on Days 1-28, palbociclib on Days 1-21, and letrozole on Days 1-28 of each 28-day cycle. Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and unequivocal disease progression.
Stage II Arm C: Inavolisib + LetrozoleParticipants will receive inavolisib in combination with letrozole on Days 1-28 of each 28-day cycle. Dose of inavolisib will be decided based on the results of Stage I Arm C. Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and unequivocal disease progression.
Stage II Arm F: Inavolisib + Palbociclib + Fulvestrant + MetforminParticipants will receive inavolisib (Days 1-28) in combination with palbociclib (Days 1-21), fulvestrant (Days 1 and 15 of Cycle 1; Day 1 for subsequent cycles) and metformin (Days 1-28)(Cycle = 28 days). Dose of inavolisib will be determined from the results of Stage I Arm B. Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and unequivocal disease progression.
Stage II Arm D: Inavolisib + FulvestrantParticipants will receive inavolisib on Days 1-28 in combination with fulvestrant on Day 1 and 15 of Cycle 1 and then on Day 1 from Cycle 2 (cycle length: 28 days). Dose of inavolisib will be decided based on the results of Stage I Arm C. Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and unequivocal disease progression.
Stage II Arm G: Inavolisib + Trastuzumab + PertuzumabParticipants will receive inavolisib in combination with trastuzumab and pertuzumab (Days 1-21). Dose of inavolisib will be determined from the results of Stage I Arm A. Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and unequivocal disease progression.
Stage I Arm A: Inavolisib Single Agent
Drug
Participants will receive inavolisib in escalating dose levels with starting dose of 6 milligrams (mg). Participants will receive single dose of inavolisib on Day 1 of Cycle 1 followed by once daily from Day 8 of Cycle 1. (Cycle length: 35 days for Cycle 1 and 28 days for all other cycles). Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and unequivocal disease progression.
Stage II Arm E: Inavolisib + Palbociclib + FulvestrantParticipants will receive inavolisib (Days 1-28) in combination with palbociclib (Days 1-21) and fulvestrant (Days 1 and 15 of Cycle 1; Day 1 for subsequent cycles)(Cycle = 28 days). Dose of inavolisib will be determined from the results of Stage I Arm B. Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and unequivocal disease progression.
Stage II Arm B: Inavolisib + Palbociclib + LetrozoleParticipants will receive inavolisib on Days 1-28 in combination with palbociclib on Days 1-21 and letrozole on Days 1-28 of each 28-day cycle. Dose of inavolisib will be decided based on the results of Stage I Arm B. Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and unequivocal disease progression.
Stage I Arm C: Inavolisib + LetrozoleParticipants will receive inavolisib in escalating dose levels along with letrozole on Days 1-28 of each 28-day cycle. The starting dose of inavolisib will not exceed the starting dose in Stage I Arm A. Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and unequivocal disease progression.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab
FDA approved
Metformin
FDA approved
Palbociclib
FDA approved
Pertuzumab
FDA approved
Fulvestrant
FDA approved
Letrozole
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline up to occurrence of complete response (cr) or partial response (pr) on 2 consecutive occasions >/=4 weeks apart (up to approximately 6 years)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline up to occurrence of complete response (cr) or partial response (pr) on 2 consecutive occasions >/=4 weeks apart (up to approximately 6 years) for reporting.

Closest Location

Columbia University Medical Center - New York, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Breast Cancer or one of the other 2 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
who were treated with the combination of palbociclib plus fulvestrant had a median overall survival of 20.4 months, compared with 10.2 months for those who received only fulvestrant The median overall survival for postmenopausal female participants with locally advanced or metastatic PIK3CA-mutant HR+/HER2- breast cancer who were treated with the combination of palbociclib plus fulvestrant was 20.4 months, compared with 10.2 months for those who received only fulvestrant. show original
is associated with significantly better outcomes The left ventricular ejection fraction is 50% or greater is associated with significantly better outcomes. show original
will be treated with palbociclib Female participants with advanced breast cancer that has a mutation in the PIK3CA gene and expresses the HER2 protein will be treated with palbociclib. show original
The patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, meaning they are fully active and able to carry out all normal activities, or they have mild symptoms that do not interfere with normal activities. show original
Each participant must provide tumor tissue from the primary or metastatic tumor site, which was obtained from a prior or new biopsy or surgical procedure for detection of PIK3CA mutation by central laboratory test. show original
treated with alpelisib had a significantly longer time to progression of disease than those treated with placebo The text discusses the results of a study that looked at the effects of alpelisib on female participants with locally advanced or metastatic PIK3CA-mutant HR+/HER2- breast cancer show original
This text refers to the life expectancy of a fetus, which is at least 12 weeks long. show original
This sentence is saying that the only people who are eligible for Arm D of the study are those with measurable disease. show original
Adequate hematologic and organ function, including blood counts, liver and kidney function
, colorectal cancer, endometrial cancer, ovarian cancer, pancreatic cancer, and other cancers - A type of cancer that has spread throughout the body and cannot be cured. show original

Patient Q&A Section

What are the common side effects of inavolisib?

"Side effects included fatigue, nausea, loss of appetite, loss of taste, and weight loss. Many patients also reported hair color changes or temporary or permanent loss of hair. Loss of hair is a known side effect in cancer treatments. If side effects interfere with patient comfort or activities of daily living, treatment may need to be discontinued." - Anonymous Online Contributor

Unverified Answer

What is the latest research for breast cancer?

"The overall breast cancer knowledge level in this sample of physicians was low. Knowledge was greatest among females and physicians who were most recently trained. Breast cancer knowledge improves over time. Research on primary prevention seems to have a role in decreasing breast cancer incidence." - Anonymous Online Contributor

Unverified Answer

What are the chances of developing breast cancer?

"The chances of developing [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) depend on many factors such as: age (at time of first pregnancy), number of children conceived, whether a mother had a history of breast or ovarian cancer, menopausal hormone therapy, family history and estrogen receptor status of the mother on pregnancy, and whether or not a mother had a history of breast cancer during childhood. Age is the major factor determining chances of developing breast cancer.\n" - Anonymous Online Contributor

Unverified Answer

Can breast cancer be cured?

"Data from a recent study suggest that a "normalisation" of normal mammograms as compared with premalignant biopsies can provide early detection of breast cancer and lead to reduced and more conservative intervention, without increasing morbidity." - Anonymous Online Contributor

Unverified Answer

How many people get breast cancer a year in the United States?

"In order to meet the needs of individuals affected by breast cancer, it is important to understand the demographic and clinical pattern of disease in different ethnic backgrounds of the United States." - Anonymous Online Contributor

Unverified Answer

What is breast cancer?

"Breast cancer is in fact not localized to the breast, but rather affects many parts of the body. The first signs of breast cancer are often noticeable and are found much later than most cancers of other types are. Breast cancer is in fact the most common cause of cancer deaths in the UK. About 1 in 6 women with breast cancer will see a doctor before symptom onset. Approximately one in nine women who present with breast cancer will have to go for treatment abroad or will be offered a travel grant." - Anonymous Online Contributor

Unverified Answer

What causes breast cancer?

"There are many possible factors, such as diet and genetics that may influence the development of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer). There is evidence that genetics is a significant factor in the development of breast cancer. A lack of exercise also seems to have a significant impact. Women with diabetes are at increased risk of developing cancer of the breast and may benefit from treatment with oral or injectable Oestrogen." - Anonymous Online Contributor

Unverified Answer

What are common treatments for breast cancer?

"In this paper, we identified different treatments for early stage [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) patients. The information is important because patients always have to talk to their doctors and health professionals and the knowledge about the treatment options can help them to understand where they are coming from in cancer treatment. We also showed that many patients undergoing adjuvant drugs after surgery." - Anonymous Online Contributor

Unverified Answer

What are the signs of breast cancer?

"The signs of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) include breast lump and an unexpected loss of feeling. Other signs include swollen lymph nodes, skin rash, and swollen neck.\n" - Anonymous Online Contributor

Unverified Answer

Does breast cancer run in families?

"The odds ratio of having breast cancer in a family member is substantially greater in families with breast cancer than in families without breast cancer (8.7), but the risk-increasing fraction is small (0.5-1.0%). Breast cancer has a relatively low penetrance. The familial risk of breast cancer is much weaker than the familial risk of breast cancer in general (in aggregate the risk of breast cancer in general is about 7.2-9.2 per 1000 women)." - Anonymous Online Contributor

Unverified Answer

What does inavolisib usually treat?

"Inavolisib is usually used as a chemotherapy, but also as a hormonal treatment for those patients with hormone receptor-positive or hormone receptor-negative luminal A [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) who have received prior endocrine therapy, for hormone receptor-positive and hormone receptor-negative HER2-positive cancer who have previously received trastuzumab. It can be used in combination with erlotinib in patients with anaplastic large cell lymphoma that is resistant to rituximab." - Anonymous Online Contributor

Unverified Answer

What is inavolisib?

"Inavosib (also known as NVP-BEZ235) is a potent oral small molecule inhibitor of the class I PI3K/AKT/mTOR pathway and also suppresses the activity of several receptor tyrosine kinases, including PDGFR and EGFR. These properties have led to multiple indications for the treatment of cancer and are now being further explored in breast cancer in a number of clinical trials. In the ING-112 study, patients were assigned either to receive either inavosib or a placebo on day 8 or day 21 of treatment cycles 2 and 3. The median PFS was 8.6 months in the inavosib arm compared to 4." - 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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