Intermittent Letrozole Therapy in Postmenopausal Women With Metastatic Breast Cancer - Full Text View

Sponsors and Collaborators:	Massachusetts General Hospital Dana-Farber Cancer Institute Novartis
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00549822

Purpose

The purpose of this research study is to study the effects of using aromatase inhibitor (AI) therapy intermittently on participants with breast cancer. AIs are a class of drugs used to treat breast cancer in postmenopausal women. They work by decreasing the level of estrogen, which is believed to stimulate the growth of tumor tissue. Breast cancer that progresses despite therapy with an AI is thought to have become resistant to AI therapy. There is scientific evidence to suggest that resistant breast cancer cells learn to grow at the very low levels of estrogen present on AI therapy, and that increasing estrogen levels even slightly by stopping AI therapy may inhibit the breast cancer cells.

Condition	Intervention	Phase
Breast Cancer	Drug: Letrozole	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Letrozole

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	A Phase II Clinical Trial of Intermittent Letrozole Therapy in Postmenopausal Women With CA 15-3 Positive, Hormone Receptor Positive, Metastatic Breast Cancer

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

To determine the proportion of patients who have a decline in serum CA 15-3 once letrozole therapy has been reintroduced after a drug free observation phase. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine the time to disease progression with intermittent letrozole. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
To measure serum HER-2/neu levels and serum/plasma angiogenic mediators. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	18
Study Start Date:	October 2007
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Intermittently

Detailed Description:

This study involves treating participants with intermittent AI therapy. The AI will be stopped at the time they enter the study. We plan on monitoring a marker in the participants blood called CA 15-3 (or CA 27.29) every 4 weeks to help us make a decision of when to re-start treatment with letrozole (femara). This marker is known to rise when disease is progressing and drop when the disease is responding to treatment. We will be stopping and re-starting therapy based on the changes of CA 15-3 in the participants blood.
In addition to bloodwork, the following tests and procedures will be performed on a monthly basis: medical history; physical examination and performance status.
Every 8 weeks the following will be performed: Tumor assessment by physical exam (if possible); Chest x-ray or CT scan or chest; CT scans of abdomen and pelvis; and bone scan.

Eligibility

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

Criteria

Inclusion Criteria:

Female
18 years of age or older
Postmenopausal
Histologically or cytologically confirmed adenocarcinoma of the breast with locally advanced or metastatic disease this is not considered amenable to curative treatment with elevation of CA 15-3 documented at the time of diagnosis of metastatic disease and prior to initiation of letrozole or anastrozole therapy
Current letrozole or anastrozole monotherapy with a documented CA 15-3 level that has decreased by at least 50% of the patients baseline
Letrozole or anastrozole must be discontinued at the time of study enrollment
Evidence of hormone sensitivity of primary or secondary tissue.
Measurable or nonmeasurable (but evaluable-defined as nontarget lesions) disease according to modified RECIST
Prior antiestrogen therapies including tamoxifen, steroidal AIs, nonsteroidal AIs, or fulvestrant in the adjuvant setting is allowed provided the patient is currently on letrozole or anastrozole monotherapy as first-line therapy for metastatic disease
Life expectancy of greater than 3 months
ECOG Performance Status of 0,1, or 2
Normal organ and marrow function as outlined in protocol

Exclusion Criteria:

Premenopausal
Trastuzumab or biologic therapy within 2 weeks
Prior or planned radiation therapy to a site of evaluable disease in the event that the site is the only site of evaluable disease
Concomitant anticancer treatments including trastuzumab, chemotherapy, or other biologic agents other than letrozole or anastrozole therapy
Chronic bisphosphonates for hypercalcemia or prevention of bone metastases.
Treatment with non-approved or investigational agent within 2 weeks before study entry
Presence of life-threatening metastatic disease, defined as extensive hepatic involvement, or past or present brain or leptomeningeal involvement, or symptomatic pulmonary lymphangitic spread
Patients who are highly symptomatic from their breast cancer, or who require urgent palliative chemotherapy, as decided by their treating physician
Previous or current systemic malignancy within the past five years, except for contralateral breast carcinoma, in situ carcinoma of the cervix treated by cone biopsy, or adequately treated basal or squamous cell carcinoma of the skin.
Any severe concomitant condition believed to render subject undesirable for participation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00549822

Contacts

Contact: Paula D Ryan, MD, Phd

617-726-5046

pdryan@partners.org

Locations

United States, Massachusetts
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02215
Principal Investigator: Paula D. Ryan, MD, PhD
Dana-Farber Cancer Institute	Recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: Leroy Parker, MD

Sponsors and Collaborators

Massachusetts General Hospital

Dana-Farber Cancer Institute

Novartis

Investigators

Principal Investigator:

Paula D. Ryan, MD, PhD

Massachusetts General Hospital

More Information

Responsible Party:	Massachusetts General Hospital ( Paula Ryan, MD, PhD )
Study ID Numbers:	07-109
Study First Received:	October 24, 2007
Last Updated:	January 7, 2008
ClinicalTrials.gov Identifier:	NCT00549822
Health Authority:	United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:

aromatase inhibitor
CA 15-3
Hormone receptor positive

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Letrozole
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Aromatase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009