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Breast CancerNCT01612247

Low Dose Chemotherapy With Aspirin in Patients With Breast Cancer After Neoadjuvant Chemotherapy

A study testing Cyclophosphamide and Methotrexate and Aspirin in people with Breast Cancer, run by University of Vermont at 3 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Patients with stage II-III breast cancer who do not achieve a pathologic complete response to neoadjuvant chemotherapy at the time of surgery will be treated with oral low dose continuous cyclophosphamide and methotrexate (CM) in combination with aspirin following surgery and radiotherapy. 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?
Cyclophosphamide and Methotrexate and Aspirin
How many people
13 participants
Where
3 sitesUnited States
Study dates
Feb 2011to Feb 2014
Phase
Interventional
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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have histologically confirmed,clinical stage II-III invasive breast cancer prior to neoadjuvant therapy (CTEP Simplified Disease Classification 10021980 or 10006190).
  • Patients may be male or female, premenopausal or postmenopausal. Tumor may be ER/PR positive or negative. Margins must be negative, with the following exception: microscopic positive anterior margin adjacent to skin is allowed.
  • Patients must receive chemotherapy prior to definitive surgery. Any preoperative chemotherapy regimen is acceptable, with the exception of anti-angiogenic agents.
  • Patients must have residual invasive breast cancer in breast and/or axillary lymph nodes by pathology at the time of surgery (not pathologic CR). All of the following clinical responses are acceptable: partial response (PR), stable disease (SD), progressive disease (PD).
  • Patients may receive hormonal therapy concurrently with study therapy. Hormonal therapy, if given, should start 4 weeks prior to initiation of study treatment in order to avoid a confounding effect on the correlative studies.
  • Age >18 years. Because breast cancer is extremely rare in this age group, children are excluded from this study.
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  • Median life expectancy of greater than 2 years.
  • ECOG performance status <1 (Karnofsky >60%; see Appendix A).
  • Patients must have normal organ and marrow function as defined below:
  • absolute neutrophil count >1.5 K/cmm
  • platelets >100 K/cmm
  • total bilirubin within normal institutional limits
  • AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal
  • creatinine within normal institutional limits OR
  • creatinine clearance >60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
  • No clinical evidence of brain metastases.
  • Patients must have QTc < 500 msec by electrocardiogram.
  • Patients must have an LVEF within institutional normal limits at baseline.
  • Patients with New York Heart Association Class I or II functional capacity are eligible. The following groups of patients are eligible provided they have New York Heart Association Class II (NYHA; see Appendix B) cardiac function at the time of baseline ECHO/MUGA:The following groups of patients are eligible provided they have New York Heart Association Class A or B
  • Patients must be registered within 180 days of definitive surgery. Treatment must start within one week of registration,
  • Because chemotherapeutic agents used in this trial are known to be teratogenic, 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 and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • Ability to understand and the willingness to sign a written informed consent document.

Who cannot join

  • Patients may not have had chemotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study and must have recovered from adverse events due to agents administered more than 4 weeks earlier.
  • Patients may not be receiving any other antineoplastic or investigational agents concurrently with study treatment with the exception of hormonal therapy.
  • Patients with HER-2 positive breast cancer are excluded.
  • History of allergic reactions attributed to aspirin or other agents used in the study.
  • Patients may not begin study treatment during radiotherapy, but may begin immediately after completing radiotherapy treatment.
  • Patients may not have received prior bevacizumab, or other anti-angiogenic agents (e.g., sorafenib, pazopanib, AZD2171, PTK787, VEGF Trap, etc.).
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  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Patients with hypertension that cannot be controlled by medications (>160/100 mmHg despite optimal medical therapy) are not eligiblePatients with poorly controlled hypertension (systolic blood pressure of 140 mmHg or higher or diastolic blood pressure of 90 mmHg or higher) are ineligible.
  • Patients on chronic aspirin therapy, anti-platelet agents, anti-coagulation agents or nonsteroidal anti-inflammatory drugs (NSAIDs) at any dose are excluded. Patients who take these drugs intermittently must be willing to abstain for the duration of the study treatment.
  • Patients with any condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease) that impairs their ability to swallow and retain oral medication are excluded.
  • Patients with any of the following conditions are excluded:
  • Prior history of gastrointestinal or central nervous system bleeding, or documented or self-reported blood in stools or bright red blood per rectum
  • Recent (within 12 months) history of clinically significant bleeding
  • Serious or non-healing wound, ulcer, or bone fracture.
  • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days of treatment.
  • Any history of cerebrovascular accident (CVA) or transient ischemic attack within 12 months prior to study entry.
  • History of myocardial infarction, cardiac arrhythmia, stable/unstable angina, symptomatic congestive heart failure, or coronary/peripheral artery bypass graft or stenting within 12 months prior to study entry.
  • History of pulmonary embolism within the past 12 months.
  • Abnormal LVEF by objective measurement. Measurement is not required unless clinically indicated, but patients are excluded if LVEF is documented to be abnormal.
  • Class III or IV heart failure as defined by the NYHA functional classification system (see Appendix B).
  • Pregnant women are excluded from this study because cyclophosphamide and methotrexate are chemotherapeutic agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with aspirin, cyclophosphamide and methotrexate, breastfeeding should not occur during study treatment. These potential risks may also apply to other agents used in this study.
  • Patients with a prior history of breast cancer, or any other malignancy other than non-melanoma skin cancer within the past five years, are excluded because recurrence of these cancers could affect the exploratory secondary endpoint of the trial.
  • Known HIV-positive patients are excluded because they are at increased risk of lethal infections when treated with marrow-suppressive therapy.

Trial locations and contacts

3 sites in 1 country.

United States3 sites, 3 recruiting

  • Maimonides Cancer Center

    Brooklyn, New York, 11220

    Susan Radoux, MD, 718-765-2644, SBurdette-Radoux@maimonidesmed.org

    Susan Radoux, MD

    Recruiting

  • University of Vermont

    Burlington, Vermont, 05401

    Marie E Wood, MD, 802-656-5487

    Kim Dittus, MD, 802-656-5487

    Recruiting

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

    Mary Chamberlin, MD, 603-653-9000

    Mary Chamberlin, MD

    Not yet recruiting

Other trials in United States

About this study

Official title: Low Dose Metronomic Cyclophosphamide and Methotrexate Chemotherapy in Combination With Aspirin in Patients With Stage II-III Breast Cancer Who Fail to Achieve a Pathologic Complete Response After Neoadjuvant Chemotherapy

Patients with stage II-III breast cancer who do not achieve a pathologic complete response to neoadjuvant chemotherapy at the time of surgery will be treated with oral low dose continuous cyclophosphamide and methotrexate (CM) in combination with aspirin following surgery and radiotherapy. The primary endpoint is to assess toxicity and safety with secondary endpoints of cytokine correlates and relapse free survival (RFS) at 2 years. The investigators design tests the null hypothesis (H0) that the true primary toxicity event rate will be 5% or less, against an alternative hypothesis (HA) event rate of 25% or more.

Conditions
Breast Cancer
Being tested
Cyclophosphamide and Methotrexate and Aspirin
Keywords
Breast Cancer, Neoadjuvant 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.

  • Cyclophosphamide and Methotrexate and AspirinDrug

    Cyclophosphamide 50 mg PO daily x 28 days, cycles 1-4 Methotrexate 2.5 mg PO twice daily, days 1 and 2 each week x 4 weeks, cycles 1-4 ASA: 325 mg PO daily x 28 days, cycles 3 and 4 Treatment will be given for a total of 4 cycles.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Toxicity and Safety

    The primary endpoint of the study is toxicity and safety. Serious adverse events, grade 3 and 4 nonhematologic toxicity, and hematologic toxicity requiring removal of the patient from study treatment will be reviewed. A fixed sample size design to test for primary toxicity events will be conducted. Sample size was selected based upon a null hypothesis that the toxicity rate will be 5% or less and that the alternative hypothesis toxicity rate will be 25% or more.

    Measured: 18 months

Secondary outcomes (1)

  1. Biomarker Analysis

    Cytokine and LVEF data will be examined using a pre-post analysis implemented using an analysis of covariance model where the pre-value serves as the baseline covariate and the post-value serves as the dependent variable of interest. Pre-post changes for each of these measures will also described in terms of 95% confidence intervals for absolute and relative changes. Other covariates may be included to examine any mediating influences on these changes dependent upon exploratory model building results.

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2012 (estimated)
  2. Study startFeb 2011
  3. Primary completionFeb 2013 (estimated)
  4. Study completionFeb 2014 (estimated)

Resources

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 N/A
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
13 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01612247
Sponsor's protocol ID
V1010
Status last verified
May 2012
First submitted
30 May 2012
Last updated
5 Jun 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Cyclophosphamide and Methotrexate and Aspirin in people with Breast Cancer, run by University of Vermont at 3 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 22 inclusion and 23 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: status not confirmed, as of the sponsor's last update on 5 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Toxicity and Safety (time frame: 18 months). 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 NCT01612247.

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 5 Jun 2012.

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