METASTATIC BREAST CANCERPhase 2NCT01818999
Ixabepilone and SBRT For Metastatic Breast Cancer
A Phase 2 study testing IXABEPILONE and STEREOTACTIC BODY RADIATION THERAPY in people with METASTATIC BREAST CANCER, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
This study is being done to find the effect of Stereotactic body radiation therapy (SBRT) in combination with Ixabepilone for women with triple negative metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- METASTATIC BREAST CANCER
- What is being tested?
- IXABEPILONE and STEREOTACTIC BODY RADIATION THERAPY
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Apr 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy proven triple negative invasive ductal or lobular metastatic breast cancer. Tumor estrogen, progesterone, and HER2 (tested by IHC or FISH) negative disease. (ER- defined as </=1% by IHC, PR- defined as </=1% by IHC, and HER2- by IHC 1+. If HER2 result by IHC is 2+ (equivocal), the tumor must be confirmed to be HER2- by FISH.
- Age ≥ 18 years.
- Patients must not have started Ixabepilone treatment more than 5 weeks prior to initiation of SBRT treatment.
- Patients can have up to 6 sites of active extracranial disease(</=3 in the liver = one site and </=3 in the lung= one site) identified by CT scan, or PET/CT, within 8 weeks prior to initiation of SBRT (up to 2 contiguous vertebral metastasis will be considered a single site of disease). Maximum number of lesions treated is deemed as feasible per the treating radiation oncologist; ie: A patient with 4 right axillary lymph nodes, L1-L2 bone metastasis, 3 lung lesions, 1 left lung lesion, 2 liver lesions, and T2-T3 bone metastasis would be defined as having 6 sites of disease. Criteria to define a lesion in any location as a metastasis requiring local treatment as one of the sites for SBRT is any lesion clinically felt to be viable; defined as enlarging on CT/MRI or having persistent FDG avidity (Either SUV>3 or increase of SUV>20% over a 6 month interval).
- Patients with skin nodules, skin invasion, or skin ulceration are eligible, if treatment with conventional radiation (at discretion of radiation oncologist) or surgery is planned. SBRT to skin nodules is not advised because of risk of skin necrosis.
- . Patients must have had failure of an anthracycline, a taxane and capecitabine as per FDA approved criteria.
Show all 21Show fewer
- Performance status of ECOG 0,1, or 2.
- Adequate organ and marrow function as defined below:
- leukocytes ≥ 3,000/mcL
- absolute neutrophil count ≥ 1,500/mcL
- platelets ≥ 100,000/mcl
- total bilirubin within normal institutional limits
- AST(SGOT)/ALT(SPGT) ≤ 2.5 X institutional upper limit of normal
- creatinine within normal institutional limits
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- 9.1 A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
- Patients who would be receiving SBRT for lung tumors who are known or must have a documented forced expiratory volume in 1 second (FEV1)>/=30%.
- Must have a CT C/A/P, or PET/CT scan within 8 weeks of enrollment.
- Ability to understand and the willingness to sign a written informed consent
Who cannot join
- Patients may not be actively receiving any other investigational agents.
- Patients with untreated brain metastasis (patients can have whole brain radiation or stereotactic radiation to brain prior to enrollment).
- Patients with leptomeningeal disease.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Agent(s) used in study. Patients with a history of severe reactions to Cremephor EL or its derivatives (polyoxyethylated castor oil) are ineligible as Ixabepilone contraindicated in these patients
- Because the tolerance dose of SBRT to the gastrointestinal tract is not established, patients with metastatic disease invading the esophagus, stomach, intestines, or mesenteric lymph nodes will not be eligible.
- Patients with more than 6 discrete extra-cranial sites.
Show all 9Show fewer
- Treatment for other carcinomas within the last 5 years, except cured non-melanoma skin and treated in-situ cancers.
- Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
- Patients must not be on concomitant CYP3A4 inhibitors or inducers (see section 4.3).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern
Dallas, Texas, 75390
About this study
Official title: A Phase II Trial Of Ixabepilone and Stereotactic Body Radiation Therapy (SBRT) For Patients With Triple Negative Metastatic Breast Cancer
This study is being done to find the effect of Stereotactic body radiation therapy (SBRT) in combination with Ixabepilone for women with triple negative metastatic breast cancer.
Read the detailed description
Ixabepilone is a FDA approved drug for the treatment of metastatic or locally advanced breast cancer after failure of chemotherapy. SBRT is a treatment method to deliver a high dose of radiation to the target, utilizing either a single dose or a small number of treatments with a high degree of precision within the body. The combination of Ixabepilone with SBRT is not an approved treatment at this time.
- Conditions
- METASTATIC BREAST CANCER
- Being tested
- IXABEPILONE, STEREOTACTIC BODY RADIATION THERAPY
- Keywords
- METASTATIC 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.
IXABEPILONEDrug
Also called Ixempra
injection
STEREOTACTIC BODY RADIATION THERAPYRadiation
Also called SBRT
SBRT will begin between 1 and 5 weeks after the initiation of Ixabepilone. Patients will receive one, three, or five fractions.
| Study group | Role | What they receive |
|---|---|---|
| arm one | Experimental | IXABEPILONE and STEREOTACTIC BODY RADIATION THERAPY (SBRT) Receives: Drug: IXABEPILONE; Radiation: STEREOTACTIC BODY RADIATION THERAPY |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of SBRT in combination with Ixabepilone on median progression free survival
To evaluate the effect of SBRT in combination with Ixabepilone on median progression free survival. Progression free survival is defined as time from initiation of treatment to progressive disease or death
Measured: 5 years
Secondary outcomes (5)
In-field local control and out-of field disease progression rates
To describe the in-field local control and out-of field disease progression rates
Measured: 5 years
Safety of SBRT in combination with Ixabepilone for patients with metastatic triple negative breast cancer after prior chemotherapy
Evaluate the safety of SBRT in combination with Ixabepilone for patients with metastatic triple negative breast cancer after prior chemotherapy
Measured: 1 year
The duration of Ixabepilone usage and time to initiation of next line systemic agent (chemotherapy or biologic agent)
Evaluate the duration of Ixabepilone usage and time to initiation of next line systemic agent (chemotherapy or biologic agent)
Measured: 5 year
Overall survival for patients with metastatic triple negative breast treated with SBRT in combination with Ixabepilone
Evaluate overall survival for patients with metastatic triple negative breast treated with SBRT in combination with Ixabepilone
Measured: 5 year
Generation of an immune response to tumor cells
Evaluate generation of an immune response to tumor cells
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2013 (estimated)
- Study startAug 2013
- Primary completionApr 2015
- Study completionApr 2015
Why it stopped: low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for METASTATIC 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Asal Rahimi, MD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01818999
- Sponsor's protocol ID
- STU 102012-020
- Status last verified
- Jan 2019
- First submitted
- 6 Mar 2013
- Last updated
- 20 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial Of Ixabepilone and Stereotactic Body Radiation Therapy (SBRT) For Patients With Triple Negative Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT01818999
- Acronym / sponsor ID
- STU 102012-020
- Conditions
- METASTATIC BREAST CANCER
- Keywords
- METASTATIC BREAST CANCER
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: low accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Aug 2013 (actual)
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 27 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to find the effect of Stereotactic body radiation therapy (SBRT) in combination with Ixabepilone for women with triple negative metastatic breast cancer.
Detailed description
Ixabepilone is a FDA approved drug for the treatment of metastatic or locally advanced breast cancer after failure of chemotherapy. SBRT is a treatment method to deliver a high dose of radiation to the target, utilizing either a single dose or a small number of treatments with a high degree of precision within the body. The combination of Ixabepilone with SBRT is not an approved treatment at this time.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| arm one | Experimental | Drug: IXABEPILONE, Radiation: STEREOTACTIC BODY RADIATION THERAPYIXABEPILONE and STEREOTACTIC BODY RADIATION THERAPY (SBRT) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Biopsy proven triple negative invasive ductal or lobular metastatic breast cancer. Tumor estrogen, progesterone, and HER2 (tested by IHC or FISH) negative disease. (ER- defined as </=1% by IHC, PR- defined as </=1% by IHC, and HER2- by IHC 1+. If HER2 result by IHC is 2+ (equivocal), the tumor must be confirmed to be HER2- by FISH.
- Age ≥ 18 years.
- Patients must not have started Ixabepilone treatment more than 5 weeks prior to initiation of SBRT treatment.
- Patients can have up to 6 sites of active extracranial disease(</=3 in the liver = one site and </=3 in the lung= one site) identified by CT scan, or PET/CT, within 8 weeks prior to initiation of SBRT (up to 2 contiguous vertebral metastasis will be considered a single site of disease). Maximum number of lesions treated is deemed as feasible per the treating radiation oncologist; ie: A patient with 4 right axillary lymph nodes, L1-L2 bone metastasis, 3 lung lesions, 1 left lung lesion, 2 liver lesions, and T2-T3 bone metastasis would be defined as having 6 sites of disease. Criteria to define a lesion in any location as a metastasis requiring local treatment as one of the sites for SBRT is any lesion clinically felt to be viable; defined as enlarging on CT/MRI or having persistent FDG avidity (Either SUV>3 or increase of SUV>20% over a 6 month interval).
- Patients with skin nodules, skin invasion, or skin ulceration are eligible, if treatment with conventional radiation (at discretion of radiation oncologist) or surgery is planned. SBRT to skin nodules is not advised because of risk of skin necrosis.
Key exclusion criteria (9 listed)
- Patients may not be actively receiving any other investigational agents.
- Patients with untreated brain metastasis (patients can have whole brain radiation or stereotactic radiation to brain prior to enrollment).
- Patients with leptomeningeal disease.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Agent(s) used in study. Patients with a history of severe reactions to Cremephor EL or its derivatives (polyoxyethylated castor oil) are ineligible as Ixabepilone contraindicated in these patients
- Because the tolerance dose of SBRT to the gastrointestinal tract is not established, patients with metastatic disease invading the esophagus, stomach, intestines, or mesenteric lymph nodes will not be eligible.
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 |
|---|---|---|
| IXABEPILONEAlso: Ixemprainjection | Drug | arm one |
| STEREOTACTIC BODY RADIATION THERAPYAlso: SBRTSBRT will begin between 1 and 5 weeks after the initiation of Ixabepilone. Patients will receive one, three, or five fractions. | Radiation | arm one |
Primary outcome
The effect of SBRT in combination with Ixabepilone on median progression free survival
Time frame: 5 years
To evaluate the effect of SBRT in combination with Ixabepilone on median progression free survival. Progression free survival is defined as time from initiation of treatment to progressive disease or death
5 secondary outcomes
In-field local control and out-of field disease progression rates
Time frame: 5 years
Safety of SBRT in combination with Ixabepilone for patients with metastatic triple negative breast cancer after prior chemotherapy
Time frame: 1 year
The duration of Ixabepilone usage and time to initiation of next line systemic agent (chemotherapy or biologic agent)
Time frame: 5 year
Overall survival for patients with metastatic triple negative breast treated with SBRT in combination with Ixabepilone
Time frame: 5 year
Generation of an immune response to tumor cells
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2020.
Related trials for METASTATIC BREAST CANCER
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruiting
Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer
Breast Cancer, Breast Neoplasms
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
RecruitingPhase 1/2
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
Metastatic Breast Cancer
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
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.
Asal Rahimi, MD principal investigator
University of Texas
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 IXABEPILONE and STEREOTACTIC BODY RADIATION THERAPY in people with METASTATIC 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 21 inclusion and 9 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: withdrawn, as of the sponsor's last update on 20 Aug 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
The effect of SBRT in combination with Ixabepilone on median 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 20 Aug 2020.