Breast CancerPhase 2NCT00138125
Fulvestrant and/or Trastuzumab as First-Line Therapy in Treating Postmenopausal Women With Stage IV Breast Cancer
A Phase 2 study testing Faslodex and Herceptin in people with Breast Cancer, run by Translational Oncology Research International at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Faslodex and Herceptin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2005to Dec 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, 90095-1781
Cancer Care Associates Medical Group, Inc
Redondo Beach, California, 90277
Study site
San Antonio, Texas
About this study
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
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.
Read the detailed description
OBJECTIVES:
Primary
- 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®).
Secondary
- 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.
- Conditions
- Breast Cancer
- Being tested
- Faslodex, Herceptin
- Keywords
- stage IV breast cancer, recurrent breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FaslodexDrug
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.
HerceptinBiological
Given at 4 mg/kg IV on day 1 (cycle 1) then 2mg/kg IV weekly
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | see intervention description for details Receives: Drug: Faslodex; Biological: Herceptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (5)
Overall Objective Response Rate
Two patients were treated on a truncated trial. Not enough data was generated for any analysis.
Measured: 5 years
Time to Tumor Progression
Two patients were treated on a truncated trial. Not enough data was generated for any analysis.
Measured: 5 years
Duration of Response
Two patients were treated on a truncated trial. Not enough data was generated for any analysis.
Measured: 5 years
Overall Survival
Two patients were treated on a truncated trial. Not enough data was generated for any analysis.
Measured: 5 years
Clinical Benefit (CR + PR + SD > 6 Months)
Two patients were treated on a truncated trial. Not enough data was generated for any analysis.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2005 (estimated)
- Study startApr 2005
- Primary completionSep 2009
- Study completionDec 2009
Why it stopped: Due to low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Translational Oncology Research International
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles, Genentech, Inc., AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Richard J. Pietras, MD, PhD, Principal investigator, Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00138125
- Sponsor's protocol ID
- CDR0000439421
- Other IDs
- UCLA-0502057-01, TORI-B-04, 441350-RI-78322
- Status last verified
- Jan 2013
- First submitted
- 29 Aug 2005
- Last updated
- 19 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00138125
- Acronym / sponsor ID
- CDR0000439421
- Conditions
- Breast Cancer
- Keywords
- stage IV breast cancer, recurrent breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to low accrual
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Translational Oncology Research InternationalUniversity, hospital or other
- Collaborators
- University of California, Los Angeles, Genentech, Inc., AstraZeneca
- Study start
- Apr 2005
- Primary completion
- Sep 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 30 Aug 2005 (estimated)
- Results
- Posted 11 Feb 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OBJECTIVES:
Primary
- 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®).
Secondary
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Drug: Faslodex, Biological: Herceptinsee intervention description for details |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Female patient, postmenopausal, defined as a woman fulfilling any one of the following criteria:
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FaslodexAdministered 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. | Drug | Arm I |
| HerceptinGiven at 4 mg/kg IV on day 1 (cycle 1) then 2mg/kg IV weekly | Biological | Arm I |
Primary outcome
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.
5 secondary outcomes
Overall Objective Response Rate
Time frame: 5 years
Time to Tumor Progression
Time frame: 5 years
Duration of Response
Time frame: 5 years
Overall Survival
Time frame: 5 years
Clinical Benefit (CR + PR + SD > 6 Months)
Time frame: 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard J. Pietras, MD, PhD principal investigator
Jonsson Comprehensive Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Faslodex and Herceptin in people with Breast Cancer, run by Translational Oncology Research International at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 28 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.