Avoiding Growth Factor During Paclitaxel Treatment in Breast Cancer

NCT02698891 | Completed Phase 2 Results DMC

• 1 other identifier: 15-516
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 4

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.

Conditions

Early Stage Breast Cancer

Keywords

Early Stage Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Rate of Paclitaxel Treatment Completion Within 7 Weeks

  Rate of participants who completed Paclitaxel treatment in 7 weeks while omitting Neulasta™ (Pegfilgrastim). Neulasta is administered based on the following pre-specified safety criteria. * The patient experiences a prior episode of fever and neutropenia. * If the patient has an active infection this decision will be at provider discretion.

  7 Weeks

Secondary Outcomes (7)

• Rate of Grade 3-5 Neutropenia

  While on study, up to 6.2 months

• Rate of Grade 3-4 Toxicities, Excluding Neutropenia

  While on study, up to 6.2 months

• Rate of Chemotherapy Dose Reductions

  While on treatment, up to 2.3 months

• Percentage of Participants Who Received All Planned Chemotherapy Cycles

  While on treatment, up to 2.3 months

• Rate of Hypersensitivity Reactions on Cycles 3-4 of Paclitaxel, When Steroid is Avoided

  While on treatment, up to 2.3 months

Study Arms (1)

Paclitaxel

EXPERIMENTAL

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.

Drug: Paclitaxel; Drug: Neulasta

Interventions

Paclitaxel DRUG

Also known as: Taxol, Onxal

Paclitaxel

Neulasta DRUG

Also known as: Pegfilgrastim

Paclitaxel

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

Study Sites (4)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Dana-Farber at Milford Regional Cancer Center

Milford, Massachusetts, 01757, United States

Location

Dana-Farber Cancer Institute at South Shore

Weymouth, Massachusetts, 02190, United States

Location

Dana-Farber/New Hampshire Oncology-Hematology

Londonderry, New Hampshire, 03053, United States

Location

Related Publications (1)

• 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.

  PMID: 32330102 DERIVED

MeSH Terms

Interventions

Paclitaxel; pegfilgrastim

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: Dr. Nancy Lin
• Organization: Dana-Farber Cancer Institute

nlin@partners.org

617-632-3800

Study Officials

• Nancy Lin, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 2, 2016
• First Posted: March 4, 2016
• Study Start: April 7, 2016
• Primary Completion: December 1, 2020
• Study Completion: November 1, 2021
• Last Updated: May 6, 2022
• Results First Posted: May 6, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)