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Early Stage Breast CancerPhase 2NCT02698891

Avoiding Growth Factor During Paclitaxel Treatment in Breast Cancer

A Phase 2 study testing Paclitaxel and Neulasta in people with Early Stage Breast Cancer, run by Dana-Farber Cancer Institute at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Early Stage Breast Cancer
What is being tested?
Paclitaxel and Neulasta
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
127 participants
Where
4 sitesUnited States
Study dates
7 Apr 2016to Nov 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Dana-Farber/New Hampshire Oncology-Hematology

    Londonderry, New Hampshire, 03053

  • Dana-Farber at Milford Regional Cancer Center

    Milford, Massachusetts, 01757

  • Dana-Farber Cancer Institute at South Shore

    Weymouth, Massachusetts, 02190

Other trials in United States

About this study

Official title: Feasibility and Safety of Avoiding Granulocyte Colony-stimulating Factor Prophylaxis During the Paclitaxel Portion of Dose Dense Doxorubicin-Cyclophosphamide and Paclitaxel Regimen

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.

Read the 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)

Being tested
Paclitaxel, Neulasta
Keywords
Early Stage Breast Cancer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PaclitaxelDrug

    Also called Taxol, Onxal

  • NeulastaDrug

    Also called Pegfilgrastim

Study groups in NCT02698891
Study groupRoleWhat they receive
PaclitaxelExperimentalAfter 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.
Receives: Drug: Paclitaxel; Drug: Neulasta

What is being measured

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

  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.

    Measured: 7 Weeks

Secondary outcomes (7)

  1. Rate of Grade 3-5 Neutropenia

    Percentage of participants experiencing grade 3-5 neutropenia per Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. while on treatment.

    Measured: While on study, up to 6.2 months

  2. Rate of Grade 3-4 Toxicities, Excluding Neutropenia

    Percentage of participants experiencing a grade 3 or 4 toxicity excluding grade 3 or 4 neutropenia or febrile neutropenia per Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

    Measured: While on study, up to 6.2 months

  3. Rate of Chemotherapy Dose Reductions

    Percentage of participants experiencing dose reductions due to adverse events.

    Measured: While on treatment, up to 2.3 months

  4. Percentage of Participants Who Received All Planned Chemotherapy Cycles

    Percentage of Participants who received all planned chemotherapy cycles.

    Measured: While on treatment, up to 2.3 months

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

    The percentage of participants who experienced a hypersensitivity reaction on cycles 3 and 4 without use of dexamethasone (a steroid)..

    Measured: While on treatment, up to 2.3 months

  6. Number of Participants With Dose Delays by Reason for Delay

    Number of participants with dose delays due to various different adverse events. Adverse events classified using CTCAEv 4.0.

    Measured: While on treatment, up to 2.3 months

  7. Median of Savings When Omitting Pegfilgrastim From Treatment.

    An algorithm was used to estimated median and range of potential savings per 100 patients if the use of pegfilgrastim was omitted from treatment. The algorithm is designed assuming an average wholesale price in the United States ranging from $1,361 to $4,655 for myeloid growth factors such as filgrastim (8 days of growth factor support/cycle) and peg-filgrastim ($5,443 to $18,622 for 4 cycles on the basis of April 2019 Medicare Part B Drug Average Sales Price), and applying a 95.7% reduction in the use of pegfilgrastim during paclitaxel.

    Measured: While on treatment, up to 2.3 months

Timeline

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

  1. First posted4 Mar 2016 (estimated)
  2. Study start7 Apr 2016
  3. Primary completionDec 2020
  4. Study completionNov 2021

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
127 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02698891
Sponsor's protocol ID
15-516
Status last verified
Apr 2022
First submitted
2 Mar 2016
Last updated
6 May 2022
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 32330102

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Paclitaxel and Neulasta in people with Early Stage Breast Cancer, run by Dana-Farber Cancer Institute at 4 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 19 inclusion and 10 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: finished, as of the sponsor's last update on 6 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Paclitaxel Treatment Completion Within 7 Weeks (time frame: 7 Weeks). 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 NCT02698891, which also lists 1 linked publication.

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 6 May 2022.

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