Breast CancerPhase 2NCT00622466
Sorafenib and Paclitaxel in Treating Patients With Metastatic Breast Cancer
A Phase 2 study testing paclitaxel and sorafenib tosylate in people with Breast Cancer, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- paclitaxel and sorafenib tosylate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2008to Oct 2016
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically* confirmed breast cancer
- Stage IV (metastatic) disease
- Radiographic evidence of metastases NOTE: *Histological confirmation of the actual metastasis is not required.
- Measurable disease by RECIST criteria defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques (i.e., physical examination, CT scan, MRI, or x-ray) or ≥ 10 mm by spiral CT scan
- No prior radiotherapy unless growth has been documented following radiotherapy
- Primary tumor or metastatic tumor HER2-negative, defined as the following:
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- Immunohistochemistry of 0 or 1+ OR the equivalent, if an automated quantitative assay is used
- HER2 fluorescent in situ hybridization (FISH) assay negative as defined by a HER2:chromosome 17 centromeric probe ratio < 1.8 (or < 2.2 if immunohistochemistry is less than 3+ or equivalent) OR equivalent values for negative FISH assays that do not normalize to chromosome 17
- Hormone-receptor positive (estrogen receptor-[ER] or progesterone receptor [PgR]-positive) disease or hormone receptor-negative (ER- or PgR-negative) disease
- Tumor block from initial breast cancer primary or a biopsy of a metastatic site must be available for correlative studies
- Brain metastases allowed provided the patient is stable after completion of treatment (i.e., surgery and/or radiotherapy), asymptomatic, and off steroids with 2 consecutive stable brain scans at least 4 weeks after radiotherapy
- ECOG performance status 0-1
- Life expectancy > 6 months
- Menopausal status not specified
- WBC ≥ 3,000/mcL
- Absolute neutrophil count ≥ 1,500/mcL
- Platelets ≥ 100,000/mcL
- Total bilirubin < 1.5 times upper limit of normal (ULN)
- AST and ALT transaminases ≤ 2.5 times ULN (< 5 times ULN if liver involvement)
- Creatinine < 1.5 times ULN OR creatinine clearance > 60 mL/min
- INR < 1.5 OR PT/PTT normal
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception prior to and during (women and men) and for at least 3 months after (men) study therapy
- Able to swallow and absorb oral medications
Who cannot join
- Bone-only or other nonmeasurable-only disease
- Newly diagnosed brain metastases
- PATIENT CHARACTERISTICS:
- Active or uncontrolled medical illness (e.g., active infection > CTCAE grade 2), including any of the following:
- HIV or chronic hepatitis B or C
- Uncontrolled diabetes
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- NYHA class II-IV uncompensated congestive heart failure
- Unstable angina (anginal symptoms at rest)
- New onset angina (i.e., began within the past 3 months)
- Coronary artery disease
- Myocardial infarction within the past 6 months
- Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
- Evidence of bleeding diathesis or coagulopathy
- Pulmonary hemorrhage/bleeding event > CTCAE grade 2 within 4 weeks of first dose of study drug
- Any other hemorrhage/bleeding event > CTCAE grade 3 within 4 weeks of first study drug
- Thrombotic or embolic events (i.e., cerebrovascular accident), including transient ischemic attacks within the past 6 months
- Hypertension that cannot be controlled with medication to ≤ 150/90 mm Hg
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to sorafenib tosylate
- Prior invasive cancer other than breast cancer except nonmelanoma skin cancer
- Chronic nonhealing wound or ulcer
- PRIOR CONCURRENT THERAPY:
- No more than 1 prior chemotherapy regimen for metastatic breast cancer (MBC)
- At least 3 weeks since prior hormonal therapy for MBC or adjuvant or neoadjuvant chemotherapy
- More than 1 year since adjuvant paclitaxel
- At least 4 weeks since major thoracic, abdominal, or pelvic surgery and recovered
- At least 3 weeks since prior and no concurrent investigational drugs
- Concurrent bisphosphonates allowed
- Concurrent anticoagulation agents (i.e., warfarin or heparin) allowed
- No anticipated need for or concurrent radiotherapy
- No concurrent Hypericum perforatum (St. John wort) or rifampin (rifampicin)
- No other concurrent anti-neoplastic drugs
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
About this study
Official title: Phase II Trial of Sorafenib and Paclitaxel for Measurable Metastatic HER2-Negative Breast Cancer
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with paclitaxel may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects of giving sorafenib together with paclitaxel and to how well it works in treating patients with metastatic breast cancer.
Read the detailed description
OBJECTIVES:
Primary
- To evaluate the efficacy of sorafenib tosylate and paclitaxel by measuring tumor response, as defined by RECIST criteria, in patients with metastatic, HER2-negative breast cancer.
Secondary
- To evaluate time to disease progression in patients treated with this regimen.
- To evaluate six-month progression-free survival of patients treated with this regimen.
- To evaluate time to treatment failure in patients treated with this regimen.
- To evaluate clinical benefit rate (tumor response and stable disease) at 24 weeks in patients treated with this regimen.
- To evaluate duration of response in patients treated with this regimen.
- To evaluate the tolerability of this regimen in these patients.
- To examine the relationship of gene expression and tissue/serum protein markers, where available, related to response to therapy focusing on growth factor receptor pathways.
OUTLINE: This is a multicenter study.
Patients receive oral sorafenib tosylate twice daily on days 1-28 and paclitaxel IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 4 weeks.
- Conditions
- Breast Cancer
- Being tested
- paclitaxel, sorafenib tosylate
- Keywords
- stage IV breast cancer, male breast cancer, recurrent breast cancer, HER2-negative breast cancer
- Medical subject headings
- Breast Neoplasms, Breast Neoplasms, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paclitaxelDrug
Also called Taxol, Abraxane, Onxol
The chemotherapy drug called paclitaxel (Taxol) treats breast cancer, lung cancer, ovarian cancer and Kaposis sarcoma
sorafenib tosylateDrug
Also called Nexavar
Sorafenib is a type of targeted therapy known as a kinase inhibitor used to treat advanced renal cell carcinoma and unresectable hepatocellular carcinoma
| Study group | Role | What they receive |
|---|---|---|
| Sorfenib + Paclitaxel | Experimental | Oral sorafenib tosylate twice daily on days 1-28 and paclitaxel IV over 1 hour on days 1, 8, and 15 Receives: Drug: paclitaxel; Drug: sorafenib tosylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Tumor Progression
Progression-free survival was defined as the time of treatment to the earliest date of documentation of disease progression or death due to any cause. In the case of a participant started treatment. Tenth month of progression-free rate of sorafenib and paclitaxel will be compared agains the null progression free rate of 32% using normal approximation test.
Measured: Time from first treatment to disease progression or death (up to 36 months)
Secondary outcomes (7)
Tumor Response Rate
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT and MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. The confirmed response rate was estimated by the number of confirmed responses divided by the total number of participants randomized.
Measured: Up to 36 months
Six-month Progression-free Survival
The proportion of patients with progression-free survival at 6 months. Progression-free is measured from Day-1 of study drug administration to disease progression as defined by Response Evaluation Criteria in Sole Tumors (RECIST) v1.1, or death on study. Progression is defined in RECIST v1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new leasions.
Measured: 6 months
Time to Treatment Failure
Number of patients experiencing treatment failure.
Measured: Up to 36 months
Clinical Benefit Rate (Tumor Response and Stable Disease) at 24 Weeks
Number of patients with either complete response (CR) or partial response (PR) as defined in Response Evaluation Criteria in Solid Tumors (for patients with measurable disease). Complete Response: Disappearance of all target lesions, disappearance of all non-target lesions for at least 4 weeks. Partial Response: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters.
Measured: 24 weeks
Duration of Response
Number weeks until disease progression measured from Day-1 of study drug administration to disease progression.
Measured: Up to 36 months
Tolerability of Sorafenib/Paclitaxel Regimen
Number of patients without experiencing treatment-related adverse events.
Measured: Up to 36 months
Determine the Relationship of Gene Expression and Tissue/Serum Protein Markers, Where Available, Related to Response to Therapy Focusing on Growth Factor Receptor Pathways.
Median values taken for all assays at baseline and relationship to response vs. no response will be made to identify predictive markers using methods to detect differential expression between two groups samples, including variants of the two-sample t-test, analysis of variance, F-test, and the Wilcoxon rank-sum test.
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2008 (estimated)
- Study start23 Apr 2008
- Primary completionOct 2016
- Study completionOct 2016
Why it stopped: Study sponsor requested that the study be permanently closed by letter.
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.
- More trials run by University of Texas Southwestern Medical CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara Haley, University of Texas Southwestern Medical Center
- Investigators
- Barbara B. Haley, MD, Principal investigator, Simmons Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00622466
- Sponsor's protocol ID
- STU 082010-161
- Other IDs
- ONYX-SCCC-112007-035, CDR0000587470, NCI-2011-02791
- Status last verified
- Sep 2020
- First submitted
- 22 Feb 2008
- 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 Trial of Sorafenib and Paclitaxel for Measurable Metastatic HER2-Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT00622466
- Acronym / sponsor ID
- STU 082010-161
- Conditions
- Breast Cancer
- Keywords
- stage IV breast cancer, male breast cancer, recurrent breast cancer, HER2-negative breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study sponsor requested that the study be permanently closed by letter.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 23 Apr 2008 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 25 Feb 2008 (estimated)
- Results
- Posted 19 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sorafenib together with paclitaxel may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects of giving sorafenib together with paclitaxel and to how well it works in treating patients with metastatic breast cancer.
Detailed description
OBJECTIVES:
Primary
- To evaluate the efficacy of sorafenib tosylate and paclitaxel by measuring tumor response, as defined by RECIST criteria, in patients with metastatic, HER2-negative breast cancer.
Secondary
- To evaluate time to disease progression in patients treated with this regimen.
- To evaluate six-month progression-free survival of patients treated with this regimen.
- To evaluate time to treatment failure in patients treated with this regimen.
- To evaluate clinical benefit rate (tumor response and stable disease) at 24 weeks in patients treated with this regimen.
- To evaluate duration of response in patients treated with this regimen.
- To evaluate the tolerability of this regimen in these patients.
- To examine the relationship of gene expression and tissue/serum protein markers, where available, related to response to therapy focusing on growth factor receptor pathways.
OUTLINE: This is a multicenter study.
Patients receive oral sorafenib tosylate twice daily on days 1-28 and paclitaxel IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sorfenib + Paclitaxel | Experimental | Drug: paclitaxel, Drug: sorafenib tosylateOral sorafenib tosylate twice daily on days 1-28 and paclitaxel IV over 1 hour on days 1, 8, and 15 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Histologically* confirmed breast cancer
- Measurable disease by RECIST criteria defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques (i.e., physical examination, CT scan, MRI, or x-ray) or ≥ 10 mm by spiral CT scan
- Primary tumor or metastatic tumor HER2-negative, defined as the following:
- Hormone-receptor positive (estrogen receptor-[ER] or progesterone receptor [PgR]-positive) disease or hormone receptor-negative (ER- or PgR-negative) disease
- Tumor block from initial breast cancer primary or a biopsy of a metastatic site must be available for correlative studies
Key exclusion criteria (31 listed)
- Bone-only or other nonmeasurable-only disease
- Newly diagnosed brain metastases
- Active or uncontrolled medical illness (e.g., active infection > CTCAE grade 2), including any of the following:
- Myocardial infarction within the past 6 months
- Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
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 |
|---|---|---|
| paclitaxelAlso: Taxol, Abraxane, OnxolThe chemotherapy drug called paclitaxel (Taxol) treats breast cancer, lung cancer, ovarian cancer and Kaposis sarcoma | Drug | Sorfenib + Paclitaxel |
| sorafenib tosylateAlso: NexavarSorafenib is a type of targeted therapy known as a kinase inhibitor used to treat advanced renal cell carcinoma and unresectable hepatocellular carcinoma | Drug | Sorfenib + Paclitaxel |
Primary outcome
Time to Tumor Progression
Time frame: Time from first treatment to disease progression or death (up to 36 months)
Progression-free survival was defined as the time of treatment to the earliest date of documentation of disease progression or death due to any cause. In the case of a participant started treatment. Tenth month of progression-free rate of sorafenib and paclitaxel will be compared agains the null progression free rate of 32% using normal approximation test.
7 secondary outcomes
Tumor Response Rate
Time frame: Up to 36 months
Six-month Progression-free Survival
Time frame: 6 months
Time to Treatment Failure
Time frame: Up to 36 months
Clinical Benefit Rate (Tumor Response and Stable Disease) at 24 Weeks
Time frame: 24 weeks
Duration of Response
Time frame: Up to 36 months
Tolerability of Sorafenib/Paclitaxel Regimen
Time frame: Up to 36 months
Determine the Relationship of Gene Expression and Tissue/Serum Protein Markers, Where Available, Related to Response to Therapy Focusing on Growth Factor Receptor Pathways.
Time frame: Up to 36 months
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.
Barbara B. Haley, MD principal investigator
Simmons Cancer Center
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 paclitaxel and sorafenib tosylate in people with Breast Cancer, run by University of Texas Southwestern Medical Center 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 25 inclusion and 31 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 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 19 Oct 2020). 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?
Time to Tumor Progression (time frame: Time from first treatment to disease progression or death (up to 36 months)). 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.