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COX Inhibition and Biomarkers During Neoadjuvant Chemoendocrine Therapy for ER+, HER2- Stage I-III Breast Cancer (Breast 51)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04038489
Recruitment Status : Recruiting
First Posted : July 30, 2019
Last Update Posted : August 4, 2020
Information provided by (Responsible Party):
Patrick Dillon, MD, University of Virginia

Brief Summary:
This study is designed to assess the safety and clinical activity of tamoxifen and the COX inhibitor, aspirin, given in combination with standard AC-T chemotherapy (doxorubicin, cyclophosphamide, and paclitaxel) for the treatment of high-risk estrogen receptor (ER)+, human epidermal growth factor receptor 2 (HER2)- breast cancer. If successful, the study could improve long-term outcomes for a subpopulation of women with aggressive stage I-III ER+/HER2- breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Estrogen Receptor-positive Breast Cancer Drug: Aspirin Drug: Tamoxifen Pill Drug: Doxorubicin Drug: Cyclophosphamide Drug: Paclitaxel Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 53 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: All participants will receive aspirin and tamoxifen with standard AC-T chemotherapy
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: COX Inhibition and Biomarkers of Response During Neoadjuvant Chemoendocrine Therapy for Estrogen Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative Stage I-III Breast Cancer
Actual Study Start Date : October 18, 2019
Estimated Primary Completion Date : April 30, 2023
Estimated Study Completion Date : April 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Tamoxifen

Arm Intervention/treatment
Experimental: Tamoxifen and Aspirin with AC-T Chemotherapy
AC-T chemotherapy includes 4 cycles of doxorubicin and cyclophosphamide given every 2 or 3 weeks followed by either 12 weekly cycles of lower dose paclitaxel or 4 cycles of higher dose paclitaxel every 2 or 3 weeks. During this time, all participants would receive daily aspirin and daily tamoxifen. After the AC-T chemotherapy, participants will undergo standard of care surgery to remove any remaining tumor.
Drug: Aspirin
325 mg aspirin daily during AC-T chemotherapy

Drug: Tamoxifen Pill
Tamoxifen (either 20 mg daily or 10 mg twice a day) during AC-T chemotherapy

Drug: Doxorubicin
Doxorubicin (60 mg/m2) Given by IV with cyclophosphamide
Other Name: Adriamycin

Drug: Cyclophosphamide
Cyclophosphamide (600 mg/m2) Given by IV with doxorubicin
Other Name: Cytoxan

Drug: Paclitaxel
Paclitaxel 80 mg/m2 or 175 mg/m2 based on provider preference. Given by IV after completion of doxorubicin/cyclophosphamide therapy
Other Name: Taxol

Primary Outcome Measures :
  1. Pathologic complete response (pCR) rate [ Time Frame: At the time of surgery, following completion of AC-T chemotherapy, usually about 7.5 months ]
    Rate of participants that no longer have any tumor identified at the time of surgery after chemotherapy

  2. Adverse events (AEs) [ Time Frame: From time of informed consent through 30 days after completion of study intervention (for AEs) or 90 days after completion of study intervention (for Serious AEs) ]
    Frequency of adverse events occurring during and shortly after the study intervention

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Provision of signed and dated informed consent form
  2. Stated willingness to comply with all study procedures and availability for the duration of the study
  3. Male or female, aged 18 or older
  4. Newly diagnosed with ER+/HER2- stage I-III breast cancer according to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines and the 8th edition of the American Joint Committee on Cancer (AJCC); ER positive is defined as ≥ 1% positive nuclear staining
  5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
  6. Life expectancy ≥ 6 months
  7. Women of childbearing potential and men must agree to use adequate contraception (see section 5.4) prior to study entry and for at least 3 months following the last dose of tamoxifen
  8. If genomic profiling has been performed (OncotypeDx, Mammaprint or other), then the score must be in a medium- or high-risk range.
  9. Adequate Organ Function as described below. There are no requirements regarding recent transfusions Absolute Neutrophil Count ≥1000/mm3 Platelets ≥100,000/mm3 Hemoglobin ≥9 g/dL Serum Creatinine or Glomerular Filtration Rate (GFR) ≤ 1.5 x upper limit of normal (ULN) Bilirubin ≤ 1.5 x ULN (except in patients with Gilbert's disease, where bilirubin to 4x ULN or direct bilirubin ≤ ULN is allowed) Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 x ULN Alkaline phosphatase ≤ 2.5 x ULN
  10. Ability to take oral medication

Exclusion Criteria:

  1. Receipt of any systemic treatment for the current diagnosis of breast cancer (breast biopsy, excisional biopsy, or other local therapy is acceptable as long as residual disease is present and is appropriate for systemic chemotherapy and additional curative intent resection)
  2. Current use of anticoagulant (e.g. warfarin (Coumadin), heparin, direct oral anticoagulants (DOAC)) within 72 hours of registration
  3. Pregnancy or lactation
  4. Currently in prison
  5. Requirement for supplemental oxygen therapy
  6. Current active cancer other than breast cancer
  7. History of severe bleeding that, in the treating investigator's opinion, would put the patient at increased risk with daily 325 mg aspirin use
  8. Known allergic reactions to aspirin, tamoxifen, doxorubicin, cyclophosphamide, or paclitaxel
  9. Participants classified according to the New York Heart Association classification as having Class II - IV heart disease (section 12.2)
  10. History of thrombosis or cerebrovascular accident

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04038489

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Contact: Olena Glushakova, MS, ACRP-CP (434) 409-6206
Contact: Stephen Hazen 434-247-7827

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United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Olena Glushakova, MS, ACRP-CP    434-409-6206   
Contact: Stephen Hazen    434-247-7827   
Principal Investigator: Patrick Dillon, MD         
Sub-Investigator: Lindsey Bazydlo, PhD         
Sub-Investigator: Christiana Brenin, MD         
Sub-Investigator: Bethany Horton, PhD         
Sub-Investigator: Melanie Rutkowski, PhD         
Sponsors and Collaborators
University of Virginia
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Principal Investigator: Patrick Dillon, MD University of Virginia
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Responsible Party: Patrick Dillon, MD, Associate Professor, University of Virginia Identifier: NCT04038489    
Other Study ID Numbers: 21822
First Posted: July 30, 2019    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Patrick Dillon, MD, University of Virginia:
ER+/HER2- Breast Cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic