Cabozantinib in Women With Metastatic Hormone-Receptor-Positive Breast Cancer - Full Text View

Purpose

The study drug cabozantinib works by inhibiting several different proteins which are believed to be involved in breast cancer tumor growth, its ability to spread, and its ability to form new blood vessels. This drug has been used in other research studies and information from those other research studies suggests that this drug may help to prevent cancer growth.

In this research study, the investigators are looking to see how effective cabozantinib is in treating your type of breast cancer.

Condition	Intervention	Phase
Breast Cancer	Drug: Cabozantinib	Phase 2

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase II Trial of Cabozantinib in Women With Metastatic Hormone-Receptor-Positive Breast Cancer With Involvement of Bone

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Cabozantinib

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

Bone Scan Response Rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
To evaluate the bone scan response rate in patients with hormone-receptor-positive breast cancer with bone metastases receiving cabozantinib. Bone scan response rate will be defined as the percentage of patients experiencing a complete resolution or significant improvement in the bone scan.

Secondary Outcome Measures:

Overall Response Rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
To evaluate overall response rate (ORR) (defined as the percentage of patients experiencing a complete response or partial response)
Overall Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
To evaluate Overall Survival
Progression Free Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
To evaluate Progression Free Survival
Effects on bone and tumor markers [ Time Frame: 2 years ] [ Designated as safety issue: No ]
To evaluate the effects of cabozantinib on biochemical markers of bone turnover and tumor markers
Skeletal related event rates (includes analgesic usage, incidence of fractures, need for radiation or surgical intervention and pain at sites of bone disease) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
All intercurrent adverse events, treatments and interventions will be recorded. For the purpose of determining the effects of cabozantinib treatment on pain and analgesic medication usage, pain will be assessed by a participant-reported questionnaire, and daily analgesic medication usage will be recorded during regular intervals.
FDG-PET (Flurodeoxyglucose Positron Emission Tomography) Response Rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
To evaluate FDG-PET response rate

Estimated Enrollment:	50
Study Start Date:	October 2011
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	November 2013 (Final data collection date for primary outcome measure)

Intervention Details:

Orally 100 mg daily in 21 day cycles

Other Name: XL184

Detailed Description:

Cabozantinib will be taken orally once a day in cycles of 21 days (3 weeks).

On Day 1 of each cycle subjects will have the following tests and procedures:

Performance status
Physical exam
Vital signs
Routine blood samples
Blood and urine samples to look at bone markers (Cycle 1 through 6 only)

Subjects will also have the following additional tests and procedures:

Tumor assessment by PET/CT scan and bone scan at Cycle 4, then every 12 weeks
Blood or urine pregnancy test (if applicable) on Day 1 of Cycles 1, 2, 4, then every 12 weeks
Urine sample and blood test for thyroid function (Cycle 1, 3, 5, then every 6 weeks)
Blood test for breast cancer tumor marker (Cycle 1 and 4, then every 6 weeks)
Pain questionnaire and painkiller medication diary at 7-day intervals during Week 3, Week 6, and every 6 weeks thereafter.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clear evidence of metastases to bone on isotope bone scan
Histologically or cytologically confirmed metastatic Estrogen-receptor-positive (ER+) and/or Progesterone-receptor-positive (PR+) and HER2 negative breast cancer
Received at least one prior line of hormonal or chemo-therapy for metastatic disease
Recovered from toxicities related to prior treatment, except alopecia, lymphopenia, or other non-clinically significant Adverse Events (AEs)
Life expectancy > 3 months
Adequate organ and marrow function
Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception
Able to lie flat for up to 45 minutes for imaging studies
Able to swallow capsules or tablets

Exclusion Criteria:

Pregnant or breast-feeding
Has experienced clinically-significant hematemesis or hemoptysis of > 0.5 teaspoons of red blood, or other signs indicative of pulmonary hemorrhage within 3 months before the first dose of study treatment
Untreated, symptomatic or uncontrolled brain metastasis requiring current treatment including steroids and anti-convulsants
Requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or coumadin-related agents, thrombin or FXa inhibitors, and antiplatelet agents (eg, clopidogrel)
Uncontrolled or significant intercurrent illness
Gastrointestinal disorders, particularly those associated with a high risk of perforation or fistula formation
Active infection requiring systemic treatment
Serious non-healing wound/ulcer/bone fracture
History of organ transplant
Concurrent uncompensated hypothyroidism or thyroid dysfunction
Previously-identified allergy or hypersensitivity to components of the study treatment formulation
Diagnosis of another malignancy, requiring systemic treatment, within the last 2 years, unless non-melanoma skin cancer, in-situ carcinoma of the cervix, or superficial bladder cancer

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01441947

Contacts

Contact: Michaela J Higgins, MD, MRCPI

617-726-4920

mjhiggins@partners.org

Locations

United States, Massachusetts
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02214
Contact: Michaela Higgins, MD 617-726-4920 mjhiggins@partners.org
Principal Investigator: Michaela J Higgins, MD, MRCPI
Dana Farber Cancer Institute	Recruiting
Boston, Massachusetts, United States
Contact: Sara Tolaney sara_tolaney@dfci.harvard.edu
Principal Investigator: Sara Tolaney, MD MPH
Beth Israel Deaconess Medical Center	Recruiting
Boston, Massachusetts, United States
Contact: Steven Come scome@bidmc.harvard.edu
Principal Investigator: Steve Come, MD
United States, New York
Memorial Sloan Kettering Cancer Center	Recruiting
New York, New York, United States, 10065
Contact: Monica Fornier, MD fornierm@mskcc.org
Contact: Deirdre Neville, RN 6468884847 nevilled@mskcc.org
Principal Investigator: Monican Fornier, MD

Sponsors and Collaborators

Massachusetts General Hospital

Exelixis

Investigators

Principal Investigator:

Michaela J Higgins, MD, MRCPI

Massachusetts General Hospital

More Information

No publications provided

Responsible Party:	Michaela J. Higgins, Principal Investigator, Attending Physician in Medical Oncology, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT01441947 History of Changes
Other Study ID Numbers:	11-208
Study First Received:	September 22, 2011
Last Updated:	January 15, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:

ER+
PR+
HER2-
metastatic

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 21, 2013