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Avoiding Growth Factor During Paclitaxel Treatment in Breast Cancer

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ClinicalTrials.gov Identifier: NCT02698891
Recruitment Status : Recruiting
First Posted : March 4, 2016
Last Update Posted : November 6, 2018
Sponsor:
Information provided by (Responsible Party):
Nancy Lin, MD, Dana-Farber Cancer Institute

Brief Summary:
This research study is testing the safety and feasibility of delivering the 4 cycles of 'dose-dense' paclitaxel without the use of Neulasta (Pegfilgrastim) as a Granulocyte Colony-stimulating Factor (G-CSF) support. The research study is for participants who have early stage breast cancer and have been recommended to receive a standard chemotherapy regimen, doxorubicin/cyclophosphamide (AC) plus Paclitaxel (T), in what is called a "dose-dense" fashion to prevent recurrences.

Condition or disease Intervention/treatment Phase
Early Stage Breast Cancer Drug: Paclitaxel Drug: Neulasta Drug: Cyclophosphamide Drug: Doxorubicin Phase 2

Detailed Description:

Low white cell blood counts increase the risk of infections; thus, in order to give each cycle of chemotherapy, white blood cell count must have recovered adequately in between cycles. Traditionally, this regimen has been given with the use of a medicine called Neulasta (Pegfilgrastim) to speed the recovery of the white blood cell count in order to maximize the chances that the next cycle of chemotherapy can be given on time.

The names of the study interventions involved in this study are:

-- Neulasta (Pegfilgrastim)


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility and Safety of Avoiding Granulocyte Colony-stimulating Factor Prophylaxis During the Paclitaxel Portion of Dose Dense Doxorubicin-Cyclophosphamide and Paclitaxel Regimen
Study Start Date : April 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Neulasta

After the screening procedures confirm participation in the research study:

Completion of 4 cycles of dose dense Adjuvant Doxorubicin Cyclophosphamide (AC)

  • Paclitaxel via IV, once every 2 week x 4 cycles
  • Neulasta™ (Pegfilgrastim) will be administered in Paclitaxel cycles, if:

    • The patient experiences a prior episode of fever and neutropenia.
    • If the patient has an active infection this decision will be at provider discretion.
    • If Neulasta™(Pegfilgrastim) is administered in any Paclitaxel cycle for a given patient, it will be then administered for all future cycles.
Drug: Paclitaxel
Other Names:
  • Taxol
  • Onxal

Drug: Neulasta
Other Name: Pegfilgrastim

Drug: Cyclophosphamide
Other Names:
  • Cytoxan®
  • Neosar®

Drug: Doxorubicin
Other Names:
  • Adriamycin®
  • Rubex®




Primary Outcome Measures :
  1. Rate of Paclitaxel Treatment Completion [ Time Frame: 7 Weeks ]
    rate of Paclitaxel treatment completion omitting Neulasta™ (Pegfilgrastim) using pre-specified safety rules within 7 weeks (from D1 of cycle 1 of Paclitaxel to D1 of cycle 4 of Paclitaxel


Secondary Outcome Measures :
  1. Incidence of grade 3-5 neutropenia [ Time Frame: 8 Weeks ]
  2. Rate of other toxicities grade 3-4 among the 4 cycles of Paclitaxel [ Time Frame: 8 weeks ]
  3. Rate of Chemotherapy Dose Reductions [ Time Frame: 8 Weeks ]
  4. Median Chemotherapy Cycle length [ Time Frame: 8 Weeks ]
  5. Percentage of participants who receive > 85% of planned chemotherapy doses [ Time Frame: 8 Weeks ]
  6. Percentage of Participants who received all planned chemotherapy cycles [ Time Frame: 8 Weeks ]
  7. Incidence of febrile neutropenia [ Time Frame: 8 weeks ]
  8. Total cost ($United States) of omitting Neulasta using planned treatment [ Time Frame: 8 weeks ]
    We will compare charges/payments for study patients versus a matched set of non-study patients who were treated with dose-dense paclitaxel and also received pegfilgrastim at Dana-Farber Cancer Institute from 2012-present. Pegfilgrastim patients will have had reimbursement for this agent, either as a facility administered medication or prescription, within the one-year observation window. Study and non-study patients will be matched based on their propensity to receive pegfilgrastim; the propensity score will be derived from a logistic regression model that includes age, race, co-morbidity and stage as covariates. Total charges/payments will be calculated during the year after diagnosis, adjusted for inflation, and expressed as 2016 $United States. We will also assess charges/payments for specific services, including facility administered medications (i.e., chemotherapy), emergency department/inpatient hospitalizations, ambulatory clinic visits, and prescriptions.

  9. Rate of hypersensitivity reactions on cycles 3-4 of Paclitaxel, when steroid is avoided [ Time Frame: 8 weeks ]
    Safety of simplifying the pre-medication regimen used for the Paclitaxel portion of the regimen (withholding premedication after 2 cycles without evidence of allergic reactions).



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have histologically or cytologically confirmed Stage I-III breast cancer (as defined by the revised, American Joint Committee on Cancer 7th edition criteria) and be at sufficient risk for tumor recurrence. Staging studies to exclude metastatic disease are not required in asymptomatic patients. However, patients with findings considered suspicious for metastatic disease on any staging studies that are obtained need to be evaluated to exclude stage IV breast cancer.
  • Patients must be deemed by their treating oncologist as candidates for (neo) adjuvant chemotherapy with dose dense AC and T.
  • Age ≥ 18 years and < 65 at the time of informed consent.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1.
  • Any grade 3 or clinically significant grade 2 treatment-related non-hematological toxicity must be resolved to grade 1 before retreatment with chemotherapy (with exception of alopecia)
  • Laboratory Evaluations:

    • Adequate blood marrow function defined as:

      • Absolute neutrophil count (ANC) ≥1500 µL
      • Hemoglobin ≥9.0 g/dl
      • Platelets ≥100,000/mm3
    • Adequate hepatic function defined as:

      • Total bilirubin ≤ 1.2 institutional upper limit of normal (ULN)
      • Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase ≤ 1.5 X upper limit normal (ULN)
    • Adequate renal function defined as:

      --- Serum creatinine ≤ 1.5 X ULN

    • Premenopausal women (including women who have had a tubal ligation and for women less than 12 months after the onset of menopause) must have a negative serum pregnancy test.
  • Patients with risk factors for Hepatitis B or C should be tested (anti-hepatitis C virus (HCV) antibody, hepatitis B surface antigen [HBsAg] or Hepatitis B core antibody). Risk factors include: history of unprotected sexual intercourse, intravenous drug use, or originally from endemic regions. If infection is suspected, hepatitis B virus (HBV) DNA and HCV RNA should be requested as appropriate.
  • Note: Patients with positive Hepatitis B or C serologies without known active disease must meet the eligibility requirements for ALT, AST, total bilirubin, and alkaline phosphatase and must have a normal international normalized ratio (INR) on at least two consecutive occasions, separated by at least 1 week, within the 30 day screening period.
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Patients who have received previous cytotoxic chemotherapy including an AC-T regimen or previous therapeutic radiation therapy for any reason in the last 5 years. Because of possible limitations in bone marrow reserve, patients with such prior treatments are not appropriate candidates for this trial. Patients who have had prior hormonal therapy (for instance, tamoxifen for prevention of breast cancer) are eligible. Patients who have participated in a window study (treatment with an investigational agent prior to surgery for ≤2 weeks) are eligible but must have discontinued the investigational agent at least 14 days before enrollment.
  • Participants who are receiving any other investigational agents
  • Have had at least one prior episode of fever and neutropenia (ANC< 500/mm3 or expected to fall below < 500/mm3) during AC.
  • Patients taking lithium.
  • Patients receiving chronic treatment with oral steroids or another immunosuppressive agent (excluding steroids as part of the chemotherapy pre-medication or emetic medication).
  • Known HIV-positive individuals or with any immunodeficiency status.
  • Patients with history of hematologic disease, including myelodysplasia or bone marrow malignancies.
  • History of allergic reaction attributed to compounds of similar chemical or biologic composition to Paclitaxel, which cannot be managed by premedication.
  • Currently pregnant or breast-feeding.
  • Uncontrolled intercurrent illness including, 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 or other significant diseases or disorders that, in the investigator's opinion, would exclude the subject from participating in the study.

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 ClinicalTrials.gov identifier (NCT number): NCT02698891


Contacts
Contact: Nancy Lin, MD 617-632-4004 nancy_lin@dfci.harvard.edu

Locations
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Dana-Farber at Milford Regional Cancer Center Recruiting
Milford, Massachusetts, United States, 01757
Contact: Michael Constantine, MD    508-488-3700    Michael_Constantine@DFCI.HARVARD.EDU   
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
Principal Investigator: Nancy Lin, MD Dana-Farber Cancer Institute

Responsible Party: Nancy Lin, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT02698891     History of Changes
Other Study ID Numbers: 15-516
First Posted: March 4, 2016    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Nancy Lin, MD, Dana-Farber Cancer Institute:
Early Stage Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Liposomal doxorubicin
Albumin-Bound Paclitaxel
Cyclophosphamide
Doxorubicin
Lenograstim
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
Adjuvants, Immunologic