Avoiding Growth Factor During Paclitaxel Treatment in Breast Cancer

NCT ID: NCT02698891

Last Updated: 2022-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 127 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-07
• Study Completion Date: 2021-11-30

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.

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)

Conditions

Early Stage Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Paclitaxel

After the screening procedures confirm participation in the research study:

175 mg/m^2 Paclitaxel via IV, once every 2 weeks x 4 cycles. (1 cycle = 2 weeks)

-- Neulasta™ (Pegfilgrastim) 6 mg SQ x1 is administered on day 2 of each treatment cycle, approximately 24 hours after the chemotherapy treatment, 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.

Group Type: EXPERIMENTAL

Paclitaxel

Intervention Type: DRUG

Neulasta

Intervention Type: DRUG

Interventions

Paclitaxel

Intervention Type: DRUG

Neulasta

Intervention Type: DRUG

Other Intervention Names

Taxol; Onxal; Pegfilgrastim

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Nancy Lin, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nancy Lin, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Dana-Farber at Milford Regional Cancer Center

Milford, Massachusetts, United States

Dana-Farber Cancer Institute at South Shore

Weymouth, Massachusetts, United States

Dana-Farber/New Hampshire Oncology-Hematology

Londonderry, New Hampshire, United States

Countries

United States

References

Vaz-Luis I, Barroso-Sousa R, Di Meglio A, Hu J, Rees R, Sinclair N, Milisits L, Leone JP, Constantine M, Faggen M, Briccetti F, Block C, O'Neil K, Partridge A, Burstein H, Waks AG, Trippa L, Tolaney SM, Hassett M, Winer EP, Lin NU. Avoiding Peg-Filgrastim Prophylaxis During the Paclitaxel Portion of the Dose-Dense Doxorubicin-Cyclophosphamide and Paclitaxel Regimen: A Prospective Study. J Clin Oncol. 2020 Jul 20;38(21):2390-2397. doi: 10.1200/JCO.19.02484. Epub 2020 Apr 24.

Reference Type: DERIVED

PMID: 32330102 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

15-516

Identifier Type: -

Identifier Source: org_study_id