Fulvestrant and/or Trastuzumab as First-Line Therapy in Treating Postmenopausal Women With Stage IV Breast Cancer

NCT00138125 | Terminated Phase 2 Results DMC

• 4 other identifiers: CDR0000439421UCLA-0502057-01TORI-B-04441350-RI-78322
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 3

Brief Summary

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using fulvestrant may fight breast cancer by lowering the amount of estrogen the body makes. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether giving fulvestrant together with trastuzumab is more effective than giving fulvestrant or trastuzumab alone in treating breast cancer. PURPOSE: This randomized phase II trial is studying how well fulvestrant and/or trastuzumab works as first-line therapy in treating postmenopausal women with stage IV breast cancer.

Conditions

Breast Cancer

Keywords

stage IV breast cancer; recurrent breast cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival

  Of the two treated patients on this trial, the records show that one patient who received Herceptin only completed 3 cycles of therapy, while the second patient who received Herceptin in combination with Faslodex completed 9 cycles of therapy. The last survival data collected from October to November 2008 showed that these two participants were alive at that time.

  5 years

Secondary Outcomes (5)

• Overall Objective Response Rate

  5 years

• Time to Tumor Progression

  5 years

• Duration of Response

  5 years

• Overall Survival

  5 years

• Clinical Benefit (CR + PR + SD > 6 Months)

  5 years

Study Arms (1)

Arm I

EXPERIMENTAL

see intervention description for details

Drug: Faslodex; Biological: Herceptin

Interventions

Faslodex DRUG

Administered IM at 500 mg on day 1 of cycle 1, followed by 500 mg on day 15 of cycle 1, then 500 mg on day 1 of each cycle thereafter.

Arm I

Herceptin BIOLOGICAL

Given at 4 mg/kg IV on day 1 (cycle 1) then 2mg/kg IV weekly

Arm I

Eligibility Criteria

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

You may qualify if:

• Female patient, postmenopausal, defined as a woman fulfilling any one of the following criteria:
• Age 60 years or older
• Age 45 years or older with amenorrhea for \> 12 months with an intact uterus
• Follicle-stimulating hormone and estradiol levels within post-menopausal range
• Having undergone a bilateral oophorectomy
• Histologically or cytologically proven adenocarcinoma of the breast
• Subjects must have archived rumor tissue available to compare the clinical response with tumor expression of biomarkers, such as HER-2, ER and PR; archived tissue will be used to confirm HER-2, ER and PR status, but results will not be used to determine subject eligibility for the study
• HER2-positive disease
• ER-positive and/or PR-positive disease
• ECOG performance status 0-2
• Life expectancy \> 24 weeks
• Left ventricular ejection fraction \> lower limit of normal
• No prior chemotherapy, endocrine therapy, Herceptin, or other biologic or investigational therapy for metastatic breast cancer
• No more than two prior endocrine agents in the adjuvant setting as single- or sequential-therapy is permitted, but no prior Faslodex therapy is permitted. A 1-month treatment-free period is required prior to receiving the first dose of trial treatments
• Prior adjuvant chemotherapy is permitted

You may not qualify if:

• Prior chemotherapy, hormonal therapy, Herceptin or other investigational therapy for metastatic breast cancer
• Prior treatment with Faslodex
• Concurrent therapy with any other non-protocol anti-cancer therapy
• Current or prior history of brain metastases
• History of any other malignancy within the past 5 years, with the exception of non-melanoma skin cancer or carcinoma-in-situ of the cervix
• Clinically significant cardiovascular disease, New York Heart Association Class II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication
• Prior exposure of \> 360 mg/m2 doxorubicin or liposomal doxorubicin, \> 120 mg/m2 mitoxantrone, \> 90 mg/m2 idarubicin, or \> 720 mg/m2 epirubicin
• Active, uncontrolled infection requiring parenteral antimicrobials
• The presence of any other medical or psychiatric disorder that, in the opinion of the treating physician, would contraindicate the use of the drugs in this protocol or place the subject at undue risk for treatment complications
• Inability to comply with the study protocol or follow-up procedures
• Known hypersensitivity to any of the drugs used in this protocol or to active or inactive excipients of Faslodex
• History of bleeding diasthesis
• Long-term anticoagulant therapy other than anti-platelet therapy, such as with warfarin

Sponsors & Collaborators

• Translational Oncology Research International: lead
• University of California, Los Angeles: collaborator
• Genentech, Inc.: collaborator
• AstraZeneca: collaborator

Study Sites (3)

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1781, United States

Location

Cancer Care Associates Medical Group, Inc

Redondo Beach, California, 90277, United States

Location

Unknown Facility

San Antonio, Texas, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Fulvestrant; Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

Trial terminated due to slow patient accrual.Study closed with two subjects enrolled to treatment phase.Slow accrual was due to specific requirements of study population limiting enrollment and possibly due to availability of study drugs in clinic.

Results Point of Contact

• Title: Richard J. Pietras, M.D. Ph.D
• Organization: University of California at Los Angeles

rpietras@ucla.edu

310 825 9769

Study Officials

• Richard J. Pietras, MD, PhD

  Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2005
• First Posted: August 30, 2005
• Study Start: April 1, 2005
• Primary Completion: September 1, 2009
• Study Completion: December 1, 2009
• Last Updated: October 19, 2020
• Results First Posted: February 11, 2013

Record last verified: 2013-01

Locations

US (3)