Metastatic Breast CancerPhase 1/2NCT00634634
Phase I/II Trial of Letrozole and Sorafenib in Post-Menopausal Hormone-Receptor + Breast Cancer
A Phase 1/2 study testing Sorafenib and Letrozole in people with Metastatic Breast Cancer, run by Rutgers, The State University of New Jersey at 4 sites in United States.
Trial summary
Letrozole is an aromatase inhibitor that is approved in the first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Sorafenib and Letrozole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 4 sitesUnited States
- Study dates
- 11 Aug 2008to 28 Apr 2023
- Phase
- Phase 1/2
- 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
- Histologically confirmed invasive breast cancer
- Stage IIIB, IIIC with T4 lesion or Stage IV disease
- Breast cancer must be ER-positive and/or PR-positive
- Age ³ 18 years of age
- ECOG performance status 0, 1 or 2
- Able to swallow and oral medication
- Adequate end organ function
- Written informed consent
Who cannot join
- Prior hormonal therapy for metastatic disease
- Prior chemotherapy for metastatic disease
- Prior treatment with sorafenib
- Brain metastases or leptomeningeal disease
- Evidence or history of bleeding
- Thrombolic or embolic events such as cerebrovascular accident including transient ischemic attacks within the past 6 months
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Emory University
Atlanta, Georgia, 30322
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
Cooper Hospital/University Medical Center
Voorhees Township, New Jersey, 08690
Georgetown University Hospital
Washington D.C., District of Columbia, 20007
About this study
Official title: Phase I/II Trial of Letrozole (Femara) and Sorafenib (Nexavar) in Postmenopausal Women With Hormone-Receptor Positive Locally Advanced or Metastatic Breast Cancer
Letrozole is an aromatase inhibitor that is approved in the first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer. Sorafenib may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. This phase I/II trial is studying the side effects and best dose of sorafenib when given in combination with letrozole and to see how well they work in treating postmenopausal women with metastatic breast cancer.
- Conditions
- Metastatic Breast Cancer
- Keywords
- breast cancer, Postmenopausal Women with Hormone Receptor-Positive Locally Advanced 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.
SorafenibDrug
Also called Nexavar
sorafenib dose will be given at a daily dose to be determined based upon the phase of study that patient is enrolled The phase II dose of sorafenib will be determined from the phase I portion of the study.
LetrozoleDrug
Also called Femara
Patients will take letrozole orally at a daily dose of 2.5 mg/day on Days 1 through 28
| Study group | Role | What they receive |
|---|---|---|
| Sorafenib and Letrozole | Experimental | Not described Receives: Drug: Sorafenib; Drug: Letrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sorafenib in Combination With Fixed Dose of of 2.5mg of Letrozole Maximum Tolerated Dose (MTD)
The highest dose of the drug that does not cause unacceptable side effects. The maximum tolerated dose be testing increasing doses until the highest dose with acceptable side effects is found.
Measured: twenty eight days
Secondary outcomes (3)
Clinical Benefit Rate Using the Response Evaluation Criteria in Solid Tumors (RECIST) Guidelines (Version 1.1) to Letrozole and Sorafenib
Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the malignant lymph nodes are used for tumor measurements. Included will be: complete response, partial response or stable disease of letrozole and sorafenib in the treatment of postmenopausal participants with hormone receptor- positive locally advanced or metastatic breast cancer.
Clinical Benefit Rate (CBR) = Progressive Free (PF) + Stable Disease (SD)
Measured: 6 months
Median Progressive-Free Survival (PFS)
PFS based on the Kaplan-Meier method is defined as the time between randomization and documented disease progression (PD) per RECIST 1,0 criteria or death, or is censored at time of last disease assessment. Per RECIST 1.0f or target lesions, PD is at least a 20% increase in sum LD of target lesions, taken as reference the smallest sum LD recorded at treatment started. Based on the time between the first day of treatment and and the date of disease progression.
Measured: Approximately 4.6 years
Overall Survival (OS) Assessed as Mean Months
From the start of treatment to the end of the study (three years) that participants are still alive. Measured by the mean number.
Measured: Approximately 4.6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2008 (estimated)
- Study start11 Aug 2008
- Primary completion20 Apr 2019
- Study completion28 Apr 2023
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 Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- Rutgers Cancer Institute of New Jersey, National Cancer Institute (NCI), Bayer, Novartis Pharmaceuticals
- Responsible party
- Principal investigator, Deborah Toppmeyer, MD, Rutgers, The State University of New Jersey
- Investigators
- Antoinette Tan, MD, Principal investigator, Rutgers Cancer Institute of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00634634
- Sponsor's protocol ID
- 040706
- Other IDs
- NJ 1107, 0220070284, NCI-2012-00525, 0220070284, Pro2018001861
- Status last verified
- Oct 2023
- First submitted
- 5 Mar 2008
- Last updated
- 9 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Trial of Letrozole (Femara) and Sorafenib (Nexavar) in Postmenopausal Women With Hormone-Receptor Positive Locally Advanced or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00634634
- Acronym / sponsor ID
- 040706
- Conditions
- Metastatic Breast Cancer
- Keywords
- breast cancer, Postmenopausal Women with Hormone Receptor-Positive Locally Advanced Breast Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- Rutgers Cancer Institute of New Jersey, National Cancer Institute (NCI), Bayer, Novartis Pharmaceuticals
- Study start
- 11 Aug 2008 (actual)
- Primary completion
- 20 Apr 2019 (actual)
- Study completion
- 28 Apr 2023 (actual)
- First posted
- 13 Mar 2008 (estimated)
- Results
- Posted 6 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Letrozole is an aromatase inhibitor that is approved in the first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer. Sorafenib may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. This phase I/II trial is studying the side effects and best dose of sorafenib when given in combination with letrozole and to see how well they work in treating postmenopausal women with metastatic breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sorafenib and Letrozole | Experimental | Drug: Sorafenib, Drug: Letrozole |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically confirmed invasive breast cancer
- Stage IIIB, IIIC with T4 lesion or Stage IV disease
- Breast cancer must be ER-positive and/or PR-positive
- Age ³ 18 years of age
- ECOG performance status 0, 1 or 2
Key exclusion criteria (6 listed)
- Prior hormonal therapy for metastatic disease
- Prior chemotherapy for metastatic disease
- Prior treatment with sorafenib
- Brain metastases or leptomeningeal disease
- Evidence or history of bleeding
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 |
|---|---|---|
| SorafenibAlso: Nexavarsorafenib dose will be given at a daily dose to be determined based upon the phase of study that patient is enrolled The phase II dose of sorafenib will be determined from the phase I portion of the study. | Drug | Sorafenib and Letrozole |
| LetrozoleAlso: FemaraPatients will take letrozole orally at a daily dose of 2.5 mg/day on Days 1 through 28 | Drug | Sorafenib and Letrozole |
Primary outcome
Sorafenib in Combination With Fixed Dose of of 2.5mg of Letrozole Maximum Tolerated Dose (MTD)
Time frame: twenty eight days
The highest dose of the drug that does not cause unacceptable side effects. The maximum tolerated dose be testing increasing doses until the highest dose with acceptable side effects is found.
3 secondary outcomes
Clinical Benefit Rate Using the Response Evaluation Criteria in Solid Tumors (RECIST) Guidelines (Version 1.1) to Letrozole and Sorafenib
Time frame: 6 months
Median Progressive-Free Survival (PFS)
Time frame: Approximately 4.6 years
Overall Survival (OS) Assessed as Mean Months
Time frame: Approximately 4.6 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Antoinette Tan, MD principal investigator
Rutgers Cancer Institute of New Jersey
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Sorafenib and Letrozole in people with Metastatic Breast Cancer, run by Rutgers, The State University of New Jersey at 4 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 8 inclusion and 6 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: finished, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 6 May 2023). 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?
Sorafenib in Combination With Fixed Dose of of 2.5mg of Letrozole Maximum Tolerated Dose (MTD) (time frame: twenty eight days). 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 9 Nov 2023.