Estrogen Receptor Positive TumorPhase 2NCT01439282
Eribulin in Combination With Capecitabine for Adjuvant Treatment in Estrogen Receptor-Positive Early Stage Breast Cancer
A Phase 2 study testing eribulin mesylate and capecitabine in people with Estrogen Receptor Positive Tumor and Breast Cancer, run by Eisai Inc. at 23 sites in United States.
Trial summary
This is a Phase 2, multicenter, single-arm, feasibility study evaluating eribulin in combination with capecitabine as an adjuvant chemotherapy regimen in approximately 65 subjects with early-stage (I-II), human epidermal growth factor receptor 2 (HER2)- normal, estrogen receptor (ER)-positive breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Estrogen Receptor Positive Tumor, Breast Cancer
- What is being tested?
- eribulin mesylate and capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 23 sitesUnited States
- Study dates
- Aug 2011to May 2014
- 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
- Male subjects aged greater than or equal to 18 years and female subjects who must be postmenopausal (at least 12 months consecutive amenorrheic or have had a bilateral oophorectomy or, if they have had a hysterectomy but with ovaries intact, then females must be age 55 or older and with postmenopausal follicle-stimulating hormone [FSH] levels).
- Subject is a candidate for chemotherapy in the adjuvant setting.
- Adjuvant therapy must begin within 84 days of the final surgical procedure for breast cancer.
- Histologically confirmed Stage I to II invasive breast cancer. Subjects may have more than one synchronous primary breast tumor.
- Receptor Status:
- HER2-normal as determined by a negative fluorescence in situ hybridization (FISH) result or 0 to 1+ by immunohistochemistry (IHC) staining result
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- ER-positive, node-negative or ER-positive Grade 1 or 2 node-positive breast cancer
- ECOG performance status of 0 or 1
- Adequate renal function as evidenced by serum creatinine less than or equal to 1.5 mg/dL or calculated creatinine clearance greater than or equal to 50 mL/min per the Cockcroft and Gault formula
- Adequate bone marrow function as evidenced by ANC greater than or equal to 1.5 x 10^9/L, hemoglobin greater than or equal to 10.0 g/dL, and platelet count greater than or equal to 100 x 10^9/L
- Adequate liver function as evidenced by bilirubin less than or equal to 1.5 times the upper limits of normal (ULN) and alkaline phosphatase, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) less than or equal to 3 x ULN
- Male subjects must have had a successful vasectomy (confirmed azoospermia), or their female partners must not be of childbearing potential, or male subjects must agree to use and have their female partners use a highly effective method of contraception (e.g., total abstinence, an intrauterine device, a double-barrier method [such as condom plus diaphragm with spermicide] throughout the entire study period and for 30 days after study drug discontinuation..
- Voluntary agreement to provide written informed consent and willingness and ability to comply with all aspects of the protocol
Who cannot join
- Stage III and IV invasive breast cancer
- Prior chemotherapy, radiation therapy, immunotherapy or biotherapy for current breast cancer
- Nonmalignant systemic disease (cardiovascular, renal, hepatic, etc) that would preclude any of the study therapy drugs
- Subjects with a concurrently active second malignancy other than adequately treated nonmelanoma skin cancers or in situ cervical cancer
- Subjects with pre-existing neuropathy greater than Grade 2
- Subjects with known positive human immunodeficiency virus (HIV) status
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- Females of childbearing potential. Females will be considered to be of childbearing potential unless they are postmenopausal (at least 12 months consecutive amenorrheic or have had a bilateral oophorectomy or, if they have had a hysterectomy but with ovaries intact, then females must be age 55 or older and with postmenopausal FSH levels).
- Subjects with current gastrointestinal disease or other condition resulting in an inability to take or absorb oral medications
- Subjects with known allergy or hypersensitivity to eribulin mesylate or its excipients, or to fluoropyrimidine therapy (with or without documented dihydropyrimidine dehydrogenase [DPD] deficiency)
- A clinically significant electrocardiogram (ECG) abnormality, including a marked baseline prolongation of QT/QTc interval (time between the start of the Q wave and the end of the T wave/QT interval corrected for heart rate) (e.g., repeated demonstration of a QTc interval greater than 500 ms)
- Any medical or other condition which, in the opinion of the investigator, would preclude participation in a clinical trial
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
New York Oncology Hematology, P.C.
Albany, New York, 12206
Texas Oncology-Austin Central
Austin, Texas, 78731
Texas Oncology-Medical City Dallas
Dallas, Texas, 75230
Texas Oncology-Dallas Presbyterian Hospital
Dallas, Texas, 75231
Texas Oncology-Methodist Charlton Cancer Center
Dallas, Texas, 75237
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246
Texas Oncology- Denton South
Denton, Texas, 76210
Texas Oncology-Fort Worth 12th Ave.
Fort Worth, Texas, 76104
Cancer Centers of the Carolinas
Greenville, South Carolina, 29605
Texas Oncology-Memorial City
Houston, Texas, 77024
Texas Oncology-Lewisville
Lewisville, Texas, 75067
Northwest Georgia Oncology Centers, P.C.
Marietta, Georgia, 30060
Virginia Oncology Associates
Norfolk, Virginia, 23502
Cancer Centers of Florida
Orlando, Florida, 32806
Texas Oncology-Paris
Paris, Texas, 75460
Cancer Care Centers of South Texas
San Antonio, Texas, 78217
Evergreen Hematology and Oncology
Spokane, Washington, 99218
Sciode Medical Associates, PLLC, d.b.a. Eastchester Center
The Bronx, New York, 10469
Arizona Oncology Associates, PC - HOPE
Tucson, Arizona, 85704
Arizona Oncology Associates, PC - CASA
Tucson, Arizona, 85715
Texas Oncology-Tyler
Tyler, Texas, 75702
Northwest Cancer Specialists, P.C.
Vancouver, Washington, 98684
Yakima Valley Memorial Hospital/North Star Lodge
Yakima, Washington, 98902
About this study
Official title: A Phase II, Multicenter, Single-Arm, Feasibility Study of Eribulin in Combination With Capecitabine for Adjuvant Treatment in Estrogen Receptor-Positive Early Stage Breast Cancer
This is a Phase 2, multicenter, single-arm, feasibility study evaluating eribulin in combination with capecitabine as an adjuvant chemotherapy regimen in approximately 65 subjects with early-stage (I-II), human epidermal growth factor receptor 2 (HER2)- normal, estrogen receptor (ER)-positive breast cancer.
- Conditions
- Estrogen Receptor Positive Tumor, Breast Cancer
- Being tested
- eribulin mesylate, capecitabine
- Keywords
- Estrogen Receptor-Positive Early Stage 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.
eribulin mesylateDrug
Also called BOLD, Halaven, E7389
Cohort I \& II: eribulin mesylate (E7389) 1.4 mg/m2 intravenously over 2 - 5 minutes on Day 1 and Day 8 for 4 cycles
capecitabineDrug
Also called Xeloda
Cohort 1: capecitabine 900 mg/m2 orally twice daily on Days 1 - 14 of a 21-day cycle for 4 cycles Cohort II: fixed dose of 1500 mg oral capecitabine twice daily, 7 days on then 7 days off for 4 cycles
| Study group | Role | What they receive |
|---|---|---|
| Eribulin + Capecitabine | Experimental | Not described Receives: Drug: eribulin mesylate; Drug: capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Achieved the Target Relative Dose Intensity (RDI) of 85%
Relative Dose Intensity (RDI) is defined as the amount of drug administered over a specific time and is expressed as the fraction of that recommended for standard of care. The RDI for each participant was calculated as follows: (1) based on each participant's body surface area (BSA), a total planned dose for both eribulin (Dep) and capecitabine (Dcp) calculated for a full 4-cycle regimen; (2) actual total dose of eribulin (Dea) and capecitabine (Dca) for the full 4-cycle regimen as collected on the case report form; (3) overall RDI = (Dea/Dep + Dca/Dcp)/2. For each individual participant, the regimen was considered feasible if that participant was able to achieve an RDI of at least 85% of the 4 cycles of eribulin plus capecitabine treatment. Missing doses due to any reason was counted as zero in the RDI calculation.
Measured: 21-Day Cycle 1 through 21-Day Cycle 4
Secondary outcomes (2)
Use of Cold Cap for Alopecia
Alopecia (hair loss) is a potential side effect of some chemotherapy agents. Chemotherapeutic drugs are toxic and could potentially harm the hair follicles (wear hair grows from) resulting in the hair falling out. It can occur in small patches on various parts of the body or all over the body and is usually temporary when related to cancer treatment. Cold cap therapy is one form of therapy for alopecia involving hair loss from the scalp. Wearing a cap or head covering with cold packs before, during, or after chemotherapy may help prevent hair loss as the cold narrows the blood vessels in the skin on your head which may lead to less of the drug reaching the hair follicles. Alopecia was one of the most common adverse events (AEs) related to eribulin only.
Measured: On the day of study drug infusion treatments during Cycles 1 through 4
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Measured: Day 1 through 30 days after last dose of study drugs (approximately up to 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2011 (estimated)
- Study startAug 2011
- Primary completionNov 2012
- Study completionMay 2014
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 Estrogen Receptor Positive TumorStudies of the same condition, open and under way.
- More trials run by Eisai Inc.The 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
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01439282
- Sponsor's protocol ID
- E7389-A001-212
- Status last verified
- May 2016
- First submitted
- 19 Sep 2011
- Last updated
- 22 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicenter, Single-Arm, Feasibility Study of Eribulin in Combination With Capecitabine for Adjuvant Treatment in Estrogen Receptor-Positive Early Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT01439282
- Acronym / sponsor ID
- E7389-A001-212
- Conditions
- Estrogen Receptor Positive Tumor, Breast Cancer
- Keywords
- Estrogen Receptor-Positive Early Stage Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2011 (actual)
- Primary completion
- Nov 2012 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 23 Sep 2011 (estimated)
- Results
- Posted 20 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 2, multicenter, single-arm, feasibility study evaluating eribulin in combination with capecitabine as an adjuvant chemotherapy regimen in approximately 65 subjects with early-stage (I-II), human epidermal growth factor receptor 2 (HER2)- normal, estrogen receptor (ER)-positive 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 |
|---|---|---|
| Eribulin + Capecitabine | Experimental | Drug: eribulin mesylate, Drug: capecitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male subjects aged greater than or equal to 18 years and female subjects who must be postmenopausal (at least 12 months consecutive amenorrheic or have had a bilateral oophorectomy or, if they have had a hysterectomy but with ovaries intact, then females must be age 55 or older and with postmenopausal follicle-stimulating hormone [FSH] levels).
- Subject is a candidate for chemotherapy in the adjuvant setting.
- Histologically confirmed Stage I to II invasive breast cancer. Subjects may have more than one synchronous primary breast tumor.
- Receptor Status:
- ECOG performance status of 0 or 1
Key exclusion criteria (11 listed)
- Stage III and IV invasive breast cancer
- Prior chemotherapy, radiation therapy, immunotherapy or biotherapy for current breast cancer
- Nonmalignant systemic disease (cardiovascular, renal, hepatic, etc) that would preclude any of the study therapy drugs
- Subjects with a concurrently active second malignancy other than adequately treated nonmelanoma skin cancers or in situ cervical cancer
- Subjects with pre-existing neuropathy greater than Grade 2
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 |
|---|---|---|
| eribulin mesylateAlso: BOLD, Halaven, E7389Cohort I \& II: eribulin mesylate (E7389) 1.4 mg/m2 intravenously over 2 - 5 minutes on Day 1 and Day 8 for 4 cycles | Drug | Eribulin + Capecitabine |
| capecitabineAlso: XelodaCohort 1: capecitabine 900 mg/m2 orally twice daily on Days 1 - 14 of a 21-day cycle for 4 cycles Cohort II: fixed dose of 1500 mg oral capecitabine twice daily, 7 days on then 7 days off for 4 cycles | Drug | Eribulin + Capecitabine |
Primary outcome
Percentage of Participants Who Achieved the Target Relative Dose Intensity (RDI) of 85%
Time frame: 21-Day Cycle 1 through 21-Day Cycle 4
Relative Dose Intensity (RDI) is defined as the amount of drug administered over a specific time and is expressed as the fraction of that recommended for standard of care. The RDI for each participant was calculated as follows: (1) based on each participant's body surface area (BSA), a total planned dose for both eribulin (Dep) and capecitabine (Dcp) calculated for a full 4-cycle regimen; (2) actual total dose of eribulin (Dea) and capecitabine (Dca) for the full 4-cycle regimen as collected on the case report form; (3) overall RDI = (Dea/Dep + Dca/Dcp)/2. For each individual participant, the regimen was considered feasible if that participant was able to achieve an RDI of at least 85% of the 4 cycles of eribulin plus capecitabine treatment. Missing doses due to any reason was counted as zero in the RDI calculation.
2 secondary outcomes
Use of Cold Cap for Alopecia
Time frame: On the day of study drug infusion treatments during Cycles 1 through 4
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Day 1 through 30 days after last dose of study drugs (approximately up to 3 years)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
23 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 eribulin mesylate and capecitabine in people with Estrogen Receptor Positive Tumor and Breast Cancer, run by Eisai Inc. at 23 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 13 inclusion and 11 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 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 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 20 Jun 2016). 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?
Percentage of Participants Who Achieved the Target Relative Dose Intensity (RDI) of 85% (time frame: 21-Day Cycle 1 through 21-Day Cycle 4). 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 22 Jun 2023.