Breast CancerPhase 2NCT00525161
Study Adding Multikinase Inhibitor Sorafenib to Existing Endocrine Therapy in Patients With Advanced Breast Cancer
A Phase 2 study testing sorafenib in people with Breast Cancer, run by Suleiman Massarweh at 1 site in United States.
Trial summary
The purpose of this study is to determine the clinical response rate to sorafenib when added to existing endocrine therapy in patients with advanced breast cancer. 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?
- sorafenib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Jan 2015
- 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
- All subjects must be female.
- Age ≥ 18 years old.
- Histologically proven carcinoma of the breast.
- Estrogen receptor and/or Progesterone positive disease.
- Metastatic or locally advanced disease.
- Patients on a preexisting endocrine agent for at least 3 months before enrollment.
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- Have residual measurable disease after
- maximal response to endocrine therapy or
- no response to endocrine therapy or
- progressive non-visceral disease on endocrine therapy.
- Must be able to provide a tumor block from either the primary or metastatic site, if available.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.
- Adequate organ function.
Who cannot join
- Patients with rapidly progressive disease on endocrine therapy who would otherwise be candidates for chemotherapy.
- Other coexisting malignancies, with the exception of basal cell carcinoma or cervical carcinoma in situ.
- Prior use of anti-angiogenic agents.
- As judged by the investigator, uncontrolled intercurrent illness.
- Known brain metastasis. Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis.
- Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment.
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- Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St John's Wort.
- Known or suspected allergy to sorafenib or any agent given in the course of this trial.
- A serious non-healing wound or ulcer.
- Evidence or history of bleeding diathesis or coagulopathy.
- Major surgery, open biopsy or significant traumatic injury within the 4 weeks prior to the first dose of the study drug.
- Pulmonary hemorrhage/bleeding event ≥ Common Toxicity Criteria for Adverse Effects (CTCAE) Grade 2 within the 4 weeks prior to the first dose of study drug.
- Pregnancy
- Any condition that impairs patient's ability to swallow whole pills.
- Documented malabsorption problem.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study of Adding the Multikinase Inhibitor Sorafenib (Nexavar) to Existing Endocrine Therapy in Patients With Advanced Breast Cancer
The purpose of this study is to determine the clinical response rate to sorafenib when added to existing endocrine therapy in patients with advanced breast cancer.
Read the detailed description
A pilot Phase II study adding sorafenib to endocrine therapy in 11 patients with metastatic estrogen receptor-positive breast cancer was conducted. Primary end point was response by Response Evaluation Criteria in Solid Tumors (RECIST) after 3 months of sorafenib. Secondary end points included safety, time to progression and biomarker modulation. The study closed early owing to slow accrual.
- Conditions
- Breast Cancer
- Being tested
- sorafenib
- Keywords
- breast cancer, Sorafenib, Nexavar, Endocrine Therapy
- 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
400 mg PO (orally) twice daily for 12 months from study enrollment or until disease progression, whichever occurs first.
| Study group | Role | What they receive |
|---|---|---|
| Sorafenib & Endocrine Therapy | Experimental | Sorafenib \& Endocrine Therapy Receives: Drug: sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Patients were followed monthly for clinical and toxicity evaluation. Disease response by RECIST criteria v1.0 was assessed after 3 months by appropriate scans and these were obtained every 2 months thereafter until progression.
Measured: 12 weeks after treatment & 8 weeks after initial documentation of response
Secondary outcomes (2)
Time to Progression
Measured: continuously
Clinical Benefit Rate
Clinical benefit rate is defined as complete response, partial response, or stable disease (CR/PR/SD) as measured by Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for a minimum of at least 24 weeks.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2007 (estimated)
- Study startOct 2007
- Primary completionJan 2013
- Study completionJan 2015
Why it stopped: Slow accrual and loss of funding
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suleiman Massarweh
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor-investigator, Suleiman Massarweh, University of Kentucky
- Investigators
- Suleiman Massarweh, MD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00525161
- Sponsor's protocol ID
- 07-BRE-41-BP
- Status last verified
- Jan 2015
- First submitted
- 3 Sep 2007
- Last updated
- 26 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Massarweh S, Moss J, Wang C, Romond E, Slone S, Weiss H, Karabakhtsian RG, Napier D, Black EP. Impact of adding the multikinase inhibitor sorafenib to endocrine therapy in metastatic estrogen receptor-positive breast cancer. Future Oncol. 2014 Dec;10(15):2435-48. doi: 10.2217/fon.14.99.
PubMed 24826798
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Adding the Multikinase Inhibitor Sorafenib (Nexavar) to Existing Endocrine Therapy in Patients With Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT00525161
- Acronym / sponsor ID
- 07-BRE-41-BP
- Conditions
- Breast Cancer
- Keywords
- breast cancer, Sorafenib, Nexavar, Endocrine Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual and loss of funding
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Suleiman MassarwehUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Oct 2007
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 5 Sep 2007 (estimated)
- Results
- Posted 13 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the clinical response rate to sorafenib when added to existing endocrine therapy in patients with advanced breast cancer.
Detailed description
A pilot Phase II study adding sorafenib to endocrine therapy in 11 patients with metastatic estrogen receptor-positive breast cancer was conducted. Primary end point was response by Response Evaluation Criteria in Solid Tumors (RECIST) after 3 months of sorafenib. Secondary end points included safety, time to progression and biomarker modulation. The study closed early owing to slow accrual.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sorafenib & Endocrine Therapy | Experimental | Drug: sorafenibSorafenib \& Endocrine Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- All subjects must be female.
- Age ≥ 18 years old.
- Histologically proven carcinoma of the breast.
- Estrogen receptor and/or Progesterone positive disease.
- Metastatic or locally advanced disease.
Key exclusion criteria (15 listed)
- Patients with rapidly progressive disease on endocrine therapy who would otherwise be candidates for chemotherapy.
- Other coexisting malignancies, with the exception of basal cell carcinoma or cervical carcinoma in situ.
- Prior use of anti-angiogenic agents.
- As judged by the investigator, uncontrolled intercurrent illness.
- Known brain metastasis. Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis.
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: Nexavar400 mg PO (orally) twice daily for 12 months from study enrollment or until disease progression, whichever occurs first. | Drug | Sorafenib & Endocrine Therapy |
Primary outcome
Response Rate
Time frame: 12 weeks after treatment & 8 weeks after initial documentation of response
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Patients were followed monthly for clinical and toxicity evaluation. Disease response by RECIST criteria v1.0 was assessed after 3 months by appropriate scans and these were obtained every 2 months thereafter until progression.
2 secondary outcomes
Time to Progression
Time frame: continuously
Clinical Benefit Rate
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24826798Massarweh S, Moss J, Wang C, Romond E, Slone S, Weiss H, Karabakhtsian RG, Napier D, Black EP. Impact of adding the multikinase inhibitor sorafenib to endocrine therapy in metastatic estrogen receptor-positive breast cancer. Future Oncol. 2014 Dec;10(15):2435-48. doi: 10.2217/fon.14.99.
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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.
Suleiman Massarweh, MD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing sorafenib in people with Breast Cancer, run by Suleiman Massarweh at 1 site 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 13 inclusion and 15 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 26 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 13 Jan 2015). 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?
Response Rate (time frame: 12 weeks after treatment & 8 weeks after initial documentation of response). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00525161, which also lists 1 linked publication.
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 26 Jan 2015.