Breast CancerPhase 2NCT02215876
Neoadjuvant Doxorubicin/Cyclophosphamide Followed by Eribulin Chemotherapy (ACE) in Operable HER2-negative Breast Cancer
A Phase 2 study testing Doxorubicin, Cyclophosphamide and Eribulin in people with Breast Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in Singapore.
Trial summary
This is a phase II, single institutional study, to evaluate a novel neo-adjuvant regimen in patients with operable, HER2-negative, breast cancer. Read more about this study
- Who is it for?
- Ages 21 to 100 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Doxorubicin, Cyclophosphamide and Eribulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSingapore
- Study dates
- Sep 2014to Mar 2020
- 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 21 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Written Informed Consent
- Target Population
- Histologically confirmed primary invasive adenocarcinoma of the breast.
- Patients with operable, T2-4, N0-3, M0, T1N1 breast cancer (stage IIA, IIB, IIIA, IIIB and IIIC) with minimum tumor size of 2 cm
- Tumors must be HER-2/neu expression negative, as determined by local hospital laboratory (IHC ≤ 2+ or FISH negative).
- No prior treatment (irradiation, chemotherapy, hormonal, immunotherapy or investigational, etc.) for breast cancer excluding therapy for DCIS. Subjects receiving hormone replacement therapy (HRT) are eligible if this therapy is discontinued at least 2 weeks before starting study therapy.
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- Subjects who received radiotherapy for DCIS may enroll.
- Disease free of prior malignancy for ≥ 5 years with the exception of curatively treated basal cell carcinoma of the skin or carcinoma in situ of the cervix.
- ECOG PS of 0 or 1.
- Accessible for treatment and follow-up.
- Baseline cardiac echocardiogram scan with LVEF of ≥ 50%.
- Adequate recovery from recent surgery. At least one week must have elapsed from minor surgery (placement of venous access device or fine needle aspiration) and at least 4 weeks from major surgery.
- Laboratory Parameters
- Absolute neutrophil count (ANC) ≥ 1500/mm3
- Total bilirubin ≤ 1.5 times the upper limit of normal (ULN).
- AST or ALT ≤ 2.5 times the upper limit of normal (ULN).
- Platelets ≥ 100,000/ mm3.
- Serum creatinine ≤ 1.5 x ULN or 24-hour creatinine clearance > 60 mL/min (measured or calculated by Cockcroft-Gault method).
- Normal PTT and either INR or PT < 1.5 x ULN.
- Age and Sex Women, at least 21 years of age. a) Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 8 weeks after the last dose of chemotherapy in such a manner that the risk of pregnancy is minimized.
- WOCBP include any woman who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation,or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea ≥ 12 consecutive months; or women on hormone replacement therapy [HRT] with documented serum follicle stimulating hormone [FSH] level > 35 mIU/mL). Even women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or whose partner is sterile (vasectomy) should be considered to be of childbearing potential.
- WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours before the first dose of investigational product.
Who cannot join
- Sex and Reproductive Status
- WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of chemotherapy.
- Women who are pregnant (including positive pregnancy test at enrollment or prior to study drug administration) or breastfeeding.
- Target Disease Exceptions
- Evidence of metastatic breast cancer following a standard tumor staging work-up.
- Evidence of inflammatory breast cancer.
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- Evidence of baseline sensory or motor neuropathy.
- Medical History and Concurrent Diseases
- Known human immunodeficiency viral (HIV) infection.
- Serious intercurrent infections or non-malignant medical illnesses that are uncontrolled or the control of which may be jeopardized by this therapy.
- Psychiatric disorders or other conditions rendering the subject incapable of complying with the requirements of the protocol.
- Clinically significant history of cardiovascular disease (history of unstable angina, congestive heart failure, uncontrolled hypertension, myocardial infarction or valvular heart disease).
- Subjects unfit for breast and/or axillary surgery (complete fixation of tumor, skin infiltration, erythema of the breast, and/or ulceration).
- Current participation in another drug trial.
- Subjects who received prior anthracycline therapy.
- Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical illness (e.g., infectious disease) must not be enrolled into this study.
- Eligibility criteria for this study have been carefully considered to ensure the safety of the study subjects and to ensure that the results of the study can be used. It is imperative that subjects fully meet all eligibility criteria.
- Allergies and Adverse Drug Reactions
- Known allergy to any of the study drugs
- Prohibited Therapies and/or Medications a) Other concurrent anti-tumor, chemotherapy, hormonal therapy, immunotherapy regimens or radiation therapy, standard or investigational.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II (Single Center) Study of Neoadjuvant Doxorubicin/Cyclophosphamide Followed by Eribulin Chemotherapy (ACE) in Operable HER2-negative Breast Cancer
This is a phase II, single institutional study, to evaluate a novel neo-adjuvant regimen in patients with operable, HER2-negative, breast cancer.
- Conditions
- Breast Cancer
- Being tested
- Doxorubicin, Cyclophosphamide, Eribulin
- Keywords
- Her 2-negative breast cancer, neoadjuvant doxorubicin/cyclophosphamide followed by Eribulin chemotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxorubicinDrug
Doxorubicin 60mg/m2 administered intravenously over 5 minutes on day 1 of a 14 of 21 days cycle IV for 4 cycles
CyclophosphamideDrug
Cyclophosphamide 600mg/m2 administered intravenously over 60 minutes on day 1 of a 14 of 21 days cycle IV for 4 cycles
EribulinDrug
Eribulin 1.4 mg/m2 administered intravenously over 2-5 minutes on days 1 and 8 of a 21 day cycle for 4 cycles
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Doxorubucin and Cyclophosphamide q2 or q3 weekly x 4 cycles plus Eribulin on days 1 and 8 of a 21 day cycle x 4 cycles Receives: Drug: Doxorubicin; Drug: Cyclophosphamide; Drug: Eribulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic Response Rate
To evaluate the pathologic complete response (pCR) rate following neoadjuvant treatment with four cycles of Doxorubicin and Cyclophosphamide (AC) and four cycles of Eribulin mesylate chemotherapy in HER2-negative operable breast cancer.
Measured: Estimated 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionAug 2017 (estimated)
- Study completionMar 2020 (estimated)
Why it stopped: No patients recruited.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe 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
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Akhil Chopra, Principal investigator, Johns Hopkins Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02215876
- Sponsor's protocol ID
- JS1405
- Other IDs
- 2013/01251
- Status last verified
- Apr 2016
- First submitted
- 6 Aug 2014
- Last updated
- 15 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II (Single Center) Study of Neoadjuvant Doxorubicin/Cyclophosphamide Followed by Eribulin Chemotherapy (ACE) in Operable HER2-negative Breast Cancer
- ClinicalTrials.gov ID
- NCT02215876
- Acronym / sponsor ID
- JS1405
- Conditions
- Breast Cancer
- Keywords
- Her 2-negative breast cancer, neoadjuvant doxorubicin/cyclophosphamide followed by Eribulin chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patients recruited.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 13 Aug 2014 (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 is a phase II, single institutional study, to evaluate a novel neo-adjuvant regimen in patients with operable, HER2-negative, 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 |
|---|---|---|
| Single Arm | Experimental | Drug: Doxorubicin, Drug: Cyclophosphamide, Drug: EribulinDoxorubucin and Cyclophosphamide q2 or q3 weekly x 4 cycles plus Eribulin on days 1 and 8 of a 21 day cycle x 4 cycles |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Signed Written Informed Consent
- Target Population
- Laboratory Parameters
- Age and Sex Women, at least 21 years of age. a) Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 8 weeks after the last dose of chemotherapy in such a manner that the risk of pregnancy is minimized.
- WOCBP include any woman who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation,or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea ≥ 12 consecutive months; or women on hormone replacement therapy [HRT] with documented serum follicle stimulating hormone [FSH] level > 35 mIU/mL). Even women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or whose partner is sterile (vasectomy) should be considered to be of childbearing potential.
Key exclusion criteria (20 listed)
- Sex and Reproductive Status
- Target Disease Exceptions
- Medical History and Concurrent Diseases
- Eligibility criteria for this study have been carefully considered to ensure the safety of the study subjects and to ensure that the results of the study can be used. It is imperative that subjects fully meet all eligibility criteria.
- Allergies and Adverse Drug Reactions
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 |
|---|---|---|
| DoxorubicinDoxorubicin 60mg/m2 administered intravenously over 5 minutes on day 1 of a 14 of 21 days cycle IV for 4 cycles | Drug | Single Arm |
| CyclophosphamideCyclophosphamide 600mg/m2 administered intravenously over 60 minutes on day 1 of a 14 of 21 days cycle IV for 4 cycles | Drug | Single Arm |
| EribulinEribulin 1.4 mg/m2 administered intravenously over 2-5 minutes on days 1 and 8 of a 21 day cycle for 4 cycles | Drug | Single Arm |
Primary outcome
Pathologic Response Rate
Time frame: Estimated 6 months
To evaluate the pathologic complete response (pCR) rate following neoadjuvant treatment with four cycles of Doxorubicin and Cyclophosphamide (AC) and four cycles of Eribulin mesylate chemotherapy in HER2-negative operable breast cancer.
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 15 Apr 2016.
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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.
Akhil Chopra principal investigator
Johns Hopkins Singapore
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 Doxorubicin, Cyclophosphamide and Eribulin in people with Breast Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in Singapore.
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 22 inclusion and 20 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 15 Apr 2016. 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 Singapore. 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?
Pathologic Response Rate (time frame: Estimated 6 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 15 Apr 2016.