Cabozantinib for Metastatic Triple Negative BrCa

NCT01738438 | Completed Phase 2 Results DMC

• 1 other identifier: 12-431
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 3

Brief Summary

In this research study, we are looking at the anti-tumor effects of Cabozantinib (XL184) in metastatic breast cancer. Data suggest that MET expression and activation are important for initiation and progression of triple-negative breast cancer (TNBC). We evaluated the efficacy of cabozantinib (XL184), a novel inhibitor of multiple receptor tyrosine kinases, including MET and VEGFR2, in patients with metastatic TNBC.

Conditions

Breast Cancer

Keywords

Metastatic; Triple Negative; Stage IV

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  The objective response rate (ORR) was defined as achieving complete response (CR) or partial response (PR) on treatment based on RECIST1.1 criteria. 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. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. Confirmatory scans were required 3 weeks following initial documentation.

  Disease was evaluated radiologically at baseline, week 6 and every 9 weeks on treatment; Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 3 cycles range (1-17).

Secondary Outcomes (1)

• Progression Free Survival

  Disease was evaluated radiologically at baseline, week 6 and every 9 weeks on treatment; Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 3 cycles range (1-17).

Study Arms (1)

Cabozantinib

EXPERIMENTAL

Cabozantinib was given at a dose of 60 mg orally once per day for 21 day cycles. Treatment continued in the absence of disease progression or unacceptable toxicity.

Drug: Cabozantinib

Interventions

Cabozantinib DRUG

Also known as: XL184

Cabozantinib

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed invasive breast cancer with stage IV disease
• Primary tumor and/or metastasis must be ER-negative, PR-negative and HER2-negative
• May have received 0-3 prior chemotherapeutic regimens for metastatic breast cancer. Must be off treatment for at least 21 days prior to enrollment
• Must have discontinued all biologic therapy at least 14 days before enrollment
• May have received prior radiation therapy in the early stage or metastatic setting, but must have completed treatment at least 14 days prior to enrollment
• Must agree to use medically acceptable methods of contraception
• Confirmed availability of formalin-fixed, paraffin-embedded tumor tissue
• Able to swallow tablets

You may not qualify if:

• Pregnant or breastfeeding
• Received another investigational agent within 14 days prior to enrollment
• Received prior c-Met inhibitor
• Known brain metastases that are untreated, symptomatic or require therapy to control symptoms
• Psychiatric illness or social situation that could limit ability to comply with study requirements
• Require concomitant treatment in therapeutic doses with anticoagulants or antiplatelet agents
• Diagnosis of another malignancy requiring systemic treatment within the last two years (except non-melanoma skin cancer or in-situ carcinoma of the cervix)
• Known to be positive for HIV
• Active infection requiring IV antibiotics at Day 1 of cycle 1
• Uncontrolled, significant intercurrent illness
• Requires chronic concomitant treatment of a strong CYP3A4 inducer
• tumor in contact with, invading or encasing major blood vessels
• Have experienced clinically significant gastrointestinal bleeding within 6 months, hemoptysis of more than 0.5 teaspoon of red blood within 3 months or other signs indicative of pulmonary hemorrhage within 3 months of enrollment

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

Study Sites (3)

Dana-Farber Cancer Institute at Faulkner Hospital

Boston, Massachusetts, 02130, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02214, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• Weber ZT, Collier KA, Tallman D, Forman J, Shukla S, Asad S, Rhoades J, Freeman S, Parsons HA, Williams NO, Barroso-Sousa R, Stover EH, Mahdi H, Cibulskis C, Lennon NJ, Ha G, Adalsteinsson VA, Tolaney SM, Stover DG. Modeling clonal structure over narrow time frames via circulating tumor DNA in metastatic breast cancer. Genome Med. 2021 May 20;13(1):89. doi: 10.1186/s13073-021-00895-x.

  PMID: 34016182 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Interventions

cabozantinib

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: Sara Tolaney, MD
• Organization: Dana-Farber Cancer Institute

Sara_Tolaney@DFCI.HARVARD.EDU

617.632.2335

Study Officials

• Sara Tolaney, MD, MPH

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: Prinicipal Investigator

Study Record Dates

• First Submitted: November 28, 2012
• First Posted: November 30, 2012
• Study Start: February 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: December 6, 2016
• Results First Posted: July 7, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)