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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00138125
Recruitment Status : Terminated (Due to low accrual)
First Posted : August 30, 2005
Results First Posted : February 11, 2013
Last Update Posted : September 12, 2018
University of California, Los Angeles
Genentech, Inc.
Information provided by (Responsible Party):
Translational Oncology Research International

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Faslodex Biological: Herceptin Phase 2

Detailed Description:



  • Compare the overall objective response rate in postmenopausal women with estrogen receptor (ER)- and/or progesterone receptor (PR)-positive, HER2/neu-overexpressing stage IV breast cancer treated with first-line therapy comprising fulvestrant and/or trastuzumab (Herceptin®).


  • Compare the duration of response in patients treated with these regimens.
  • Compare overall survival of patients treated with these regimens.
  • Compare the antitumor activity of these regimens, in terms of time to disease progression, in these patients.
  • Compare the clinical benefit of these regimens in these patients.
  • Determine the safety and toxicity of these regimens in these patients.
  • Correlate HER2/neu expression and ER and/or PR expression with response in patients treated with these regimens.

OUTLINE: This is a randomized, controlled, open-label, multicenter study. Patients are stratified according to prior adjuvant endocrine therapy (yes vs no). Patients are randomized to 1 of 3 treatment arms.

  • Arm I: Patients receive fulvestrant intramuscularly on days 1 and 15 of course 1 and then on day 1 only in all subsequent courses.
  • Arm II: Patients receive trastuzumab (Herceptin®) IV over 30-90 minutes on days 1, 8, 15, and 22.
  • Arm III: Patients receive fulvestrant as in arm I in combination with trastuzumab as in arm II.

In all arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 8 weeks.

PROJECTED ACCRUAL: A total of 120 patients (40 per treatment arm) will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Randomized Trial of Faslodex and Herceptin, Alone and Combined, in the First - Line Treatment of Hormone Receptor-Positive, HER-2/Neu-Overexpressing Metastatic Breast Cancer
Study Start Date : April 2005
Actual Primary Completion Date : September 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Fulvestrant

Arm Intervention/treatment
Experimental: Arm I
see intervention description for details
Drug: Faslodex
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.

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

Primary Outcome Measures :
  1. Progression-free Survival [ Time Frame: 5 years ]
    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.

Secondary Outcome Measures :
  1. Overall Objective Response Rate [ Time Frame: 5 years ]
    Two patients were treated on a truncated trial. Not enough data was generated for any analysis.

  2. Time to Tumor Progression [ Time Frame: 5 years ]
    Two patients were treated on a truncated trial. Not enough data was generated for any analysis.

  3. Duration of Response [ Time Frame: 5 years ]
    Two patients were treated on a truncated trial. Not enough data was generated for any analysis.

  4. Overall Survival [ Time Frame: 5 years ]
    Two patients were treated on a truncated trial. Not enough data was generated for any analysis.

  5. Clinical Benefit (CR + PR + SD > 6 Months) [ Time Frame: 5 years ]
    Two patients were treated on a truncated trial. Not enough data was generated for any analysis.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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
  • Prior adjuvant Herceptin permitted
  • At least 1 month since prior surgery, radiotherapy, or endocrine therapy, with complete recovery from the effects of these interventions
  • Patients must have ended any hormone replacement therapy at least 1 month prior to receiving the first dose of trial therapy
  • Patients treated with bisphosphonates may enroll, with heir bone lesions only assessable for disease progression
  • Patient is accessible and willing to comply with treatment and follow-up
  • Patient is willing to provide written informed consent prior to the performance of any study-related procedures
  • Required laboratory values:

    • Absolute neutrophil count > 1.5 x 10^9/L
    • Hemoglobin > 10g/dL
    • Platelet count > 100 x 10^9/L
    • Creatinine < 2.0 mg/dL
    • Total bilirubin < 1.5 x upper limit of normal
    • AST and ALT < 2.5 x ULN

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00138125

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United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
Cancer Care Associates Medical Group, Inc
Redondo Beach, California, United States, 90277
United States, Texas
San Antonio, Texas, United States
Sponsors and Collaborators
Translational Oncology Research International
University of California, Los Angeles
Genentech, Inc.
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Principal Investigator: Richard J. Pietras, MD, PhD Jonsson Comprehensive Cancer Center

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Responsible Party: Translational Oncology Research International Identifier: NCT00138125     History of Changes
Obsolete Identifiers: NCT00203437
Other Study ID Numbers: CDR0000439421
UCLA-0502057-01 ( Other Identifier: UCLA IRB )
TORI-B-04 ( Other Identifier: UCLA )
441350-RI-78322 ( Other Grant/Funding Number: Genentech and AstraZeneca )
First Posted: August 30, 2005    Key Record Dates
Results First Posted: February 11, 2013
Last Update Posted: September 12, 2018
Last Verified: January 2013
Keywords provided by Translational Oncology Research International:
stage IV breast cancer
recurrent breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs