Efficacy and Safety of 500mg of Fulvestrant as a First Line Hormonal Treatment in Postmenopausal Women With Hormone Receptor Positive Metastatic Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Massachusetts General Hospital
Lowell General Hospital
University of Colorado, Denver
University of Maryland Greenebaum Cancer Center
South Shore Hospital
Information provided by (Responsible Party):
Steven Come, MD, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00585507
First received: December 22, 2007
Last updated: January 15, 2014
Last verified: January 2014
  Purpose

Fulvestrant has proven effective in the treatment of hormone receptor positive metastatic breast cancer. The dose used in studies so far has been well tolerated and may be too low for optimal effectiveness. In this study, a higher dose will be used to see whether an improved outcome will result.


Condition Intervention Phase
Breast Cancer
Drug: Fulvestrant
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Multi-Center Study to Evaluate the Efficacy and Safety of 500mg of Fulvestrant (Faslodex) as a First Line Hormonal Treatment in Postmenopausal Women With Hormone Receptor Positive Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • To assess the clinical benefit rate for subjects receiving this dose and schedule of fulvestrant. [ Time Frame: TBD ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall objective response rate, time to response, duration of response, duration of clinical benefit, and time to progression. [ Time Frame: TBD ] [ Designated as safety issue: No ]
  • Assessment of adverse events [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Assessment of pharmacokinetics of this dose and schedule of fulvestrant. [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: April 2004
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: single
fulvestrant 500mg
Drug: Fulvestrant
500mg into the muscle on days 1, 15 and 29 and then every 28 days thereafter.
Other Name: Faslodex

Detailed Description:
  • Fulvestrant will be administered by intramuscular injection on day 1, day 15 and day 29 and then every 28 days thereafter.
  • Participants will have a physical examination and blood work performed on each treatment date. After teh study treatment has been completed, the physical examinations will be done every three months for the first 2 years, every 6 months for years 2-5, and annually after 5 years.
  • Participants may remain on study treatment until disease progression or until they experience serious side effects.
  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
  • Histologically confirmed adenocarcinoma of the breast progressing local-regional or metastatic disease that is not considered amenable to curative treatment
  • Evidence of hormone sensitivity of primary or secondary tumor tissue
  • Postmenopausal as defined by criteria listed in protocol
  • May have had adjuvant endocrine therapy if discontinued at least 12 months prior to inclusion. Subjects who have had minimal exposure to adjuvant or first line metastatic endocrine treatment during the 12 months prior to study enrollment can be eligible with overall PI and sponsor permission
  • Prior trastuzumab and biologic therapy is allowed, but must be discontinued more than 2 weeks prior to inclusion
  • Presence of measurable or evaluable, nonmeasurable, disease. Any x-rays and scans for assessment of measurable disease must be performed with 28 days prior to registration
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2

Exclusion Criteria:

  • Presence of life-threatening metastatic disease
  • Endocrine therapy the advanced disease setting
  • Systemic chemotherapy, whether as adjuvant therapy or for advanced disease, within previous 4 weeks
  • Trastuzumab or biologic therapy within previous 2 weeks
  • Extensive radiation therapy within the last 2 weeks
  • Prior adjuvant or neoadjuvant treatment with fulvestrant is not allowed
  • Concomitant anticancer treatments
  • Chronic bisphosphonates for hypercalcemia or prevention of bone metastases
  • Subjects receiving long-term anticoagulant therapy with warfarin
  • Estrogen replacement therapy within 6 months of trial entry
  • Previous or current systems malignancy within the past 3 years
  • Treatment with non approved or investigational drug within 2 weeks before study entry
  • Any evidence of severe or uncontrolled systemic disease
  • History of bleeding diathesis
  • Any severe concomitant condition which makes it undesirable for the subject to participate in the study or which would jeopardize compliance with the study protocol
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00585507

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hosptial
Boston, Massachusetts, United States, 02114
Lowell General Hospital
Lowell, Massachusetts, United States, 01854
South Shore Hospital
S. Weymouth, Massachusetts, United States, 02190
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Massachusetts General Hospital
Lowell General Hospital
University of Colorado, Denver
University of Maryland Greenebaum Cancer Center
South Shore Hospital
Investigators
Principal Investigator: Steven Come, MD Beth Israel Deaconess Medical Center
  More Information

No publications provided

Responsible Party: Steven Come, MD, Principal Investigator, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00585507     History of Changes
Other Study ID Numbers: 04-016
Study First Received: December 22, 2007
Last Updated: January 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
hormone receptor positive breast cancer
Fulvestrant

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Hormones
Estradiol
Fulvestrant
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Antineoplastic Agents, Hormonal
Estrogens

ClinicalTrials.gov processed this record on July 22, 2014