BKM120 For Triple Negative Breast Cancer

NCT01790932 | Completed Phase 2 Results DMC

• 1 other identifier: 12-438
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 4

Brief Summary

Triple negative breast cancer (TNBC) has an aggressive phenotype and poor prognosis. This tumor type characterized by lack of expression of estrogen receptor (ER), progesterone receptor (PR) and no amplification of the human epidermal growth factor 2 (HER2) accounts for 15% of breast cancers. Limited treatment options exist in the clinic as hormonal therapies and HER2-trageted agents have proven ineffective. BKM120 is a drug that works by blocking a protein called phosphatidylinositol-3-kinase (PI3K) which may contribute to cancer growth. This drug has been used in experiments in the laboratory and information from these research studies suggests that BKM120 may help to prevent cancer cells from growing. In this research study, the investigators are looking to see if BKM120 works to stop breast cancer cells from growing.

Conditions

Breast Cancer

Keywords

Metastatic; Triple Negative

Outcome Measures

Primary Outcomes (1)

• Clinical Benefit Rate

  Clinical benefit rate (CBR) was defined as the proportion of participants achieving complete response (CR), partial response (PR), or stable disease (SD) for 4 months or longer based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PD is at least a 20% increase in sum LD of target lesions (smallest sum LD reference), new lesions, and/or unequivocal progression of existing non-target lesions. Stable disease (SD) is defined as any condition not meeting the above criteria.

  Disease was evaluated radiologically at baseline and every 2 cycles on treatment then every 3 months up to 2 years. Participants in this study cohort were followed for response on average approximately 2 months.

Secondary Outcomes (2)

• Progression Free Survival

  Disease was evaluated radiologically at baseline and every 2 cycles on treatment then every 3 months up to 2 years. Participants in this study cohort were followed for PFS on average approximately 2 months.

• Overall Survival

  Participants were assessed every 3 months post-treatment up to 2 years. Average survival follow-up for the study cohort was 13.8 months.

Study Arms (1)

BKM120

EXPERIMENTAL

BKM120: 100 mg capsule once daily each day of a 28 day cycle . Treatment with BKM120 will continue until disease progression, unacceptable toxicity or withdrawal for other reasons.

Drug: BKM120

Interventions

BKM120 DRUG

Also known as: Buparlisib

BKM120

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically and radiologically confirmed metastatic triple negative breast cancer
• Up to two prior lines of chemotherapy for metastatic breast cancer
• Availability of a representative tumor specimen
• At least one measurable lesion

You may not qualify if:

• Have received previous treatment with PI3K inhibitors
• Symptomatic central nervous system (CNS) metastases (controlled and asymptomatic CNS metastases are acceptable)
• Concurrent malignancy or has a malignancy within 3 years of study enrollment
• Any of the following mood disorders: active major depressive episode, bipolar disorder, obsessive-compulsive disorder, schizophrenia, history of suicidal attempt or ideation, homicidal ideation, greater than or equal to Common Toxicity Criteria for Adverse Events (CTCAE) grade 3 anxiety
• Concurrently using other approved or investigational antineoplastic agent and/or chemotherapy within 21 days prior to enrollment in this study
• Has received radiation therapy within 28 days prior to enrollment in this study or has not recovered from side effects of such therapy
• Major surgery within 28 days of starting therapy or has not recovered from major side effects of a previous surgery
• Poorly controlled diabetes mellitus
• History of cardiac dysfunction
• Currently receiving treatment with QT prolonging medication and the treatment cannot be discontinued or switched to a different medication
• Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BKM120
• Receiving chronic treatment with steroids or another immunosuppressive agent
• Other concurrent severe and/or uncontrolled medical condition that would contraindicate participation in this study
• History of non-compliance to a medical regimen
• Currently being treated with drugs known to be moderate or strong inhibitors or inducers of isoenzyme Cytochrome P450, family 3, subfamily A (CYP3A)

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

Study Sites (4)

Dana-Farber Cancer Institute at Faulkner Hospital

Boston, Massachusetts, 02130, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• Garrido-Castro AC, Saura C, Barroso-Sousa R, Guo H, Ciruelos E, Bermejo B, Gavila J, Serra V, Prat A, Pare L, Celiz P, Villagrasa P, Li Y, Savoie J, Xu Z, Arteaga CL, Krop IE, Solit DB, Mills GB, Cantley LC, Winer EP, Lin NU, Rodon J. Phase 2 study of buparlisib (BKM120), a pan-class I PI3K inhibitor, in patients with metastatic triple-negative breast cancer. Breast Cancer Res. 2020 Nov 2;22(1):120. doi: 10.1186/s13058-020-01354-y.

  PMID: 33138866 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Interventions

NVP-BKM120

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Nancy Lin, MD
• Organization: Dana-Farber Cancer Institute

nlin@partners.org

617.632.2335

Study Officials

• Nancy Lin, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 7, 2013
• First Posted: February 13, 2013
• Study Start: June 1, 2012
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: January 23, 2019
• Results First Posted: January 23, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)