filgrastim for Breast Cancer

Phase-Based Progress Estimates
Cancer Center and Beckman Research Institute, City of Hope, Duarte, CABreast Cancerfilgrastim - Biological
18 - 59
All Sexes
What conditions do you have?

Study Summary

This trial is studying how well combination chemotherapy, amifostine, and peripheral stem cell transplantation works in treating patients with breast cancer.

Eligible Conditions
  • Breast Cancer

Treatment Effectiveness

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: Up to death

Up to death
Feasibility of high dose chemotherapy in advance breast cancer patients.

Trial Safety

Trial Design

1 Treatment Group

High Dose chemotherapy followed by cell rescue
1 of 1

Experimental Treatment

15 Total Participants · 1 Treatment Group

Primary Treatment: filgrastim · No Placebo Group · Phase 1

High Dose chemotherapy followed by cell rescueExperimental Group · 6 Interventions: amifostine trihydrate, peripheral blood stem cell transplantation, doxorubicin hydrochloride, cyclophosphamide, filgrastim, paclitaxel · Intervention Types: Drug, Procedure, Drug, Drug, Biological, Drug
First Studied
Drug Approval Stage
How many patients have taken this drug
FDA approved
peripheral blood stem cell transplantation
Completed Phase 3
FDA approved
FDA approved
FDA approved
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to death

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
524 Previous Clinical Trials
2,249,963 Total Patients Enrolled
42 Trials studying Breast Cancer
6,634 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,153 Previous Clinical Trials
41,162,909 Total Patients Enrolled
927 Trials studying Breast Cancer
1,536,834 Patients Enrolled for Breast Cancer
George Somlo, MDStudy ChairCity of Hope Comprehensive Cancer Center
10 Previous Clinical Trials
534 Total Patients Enrolled
6 Trials studying Breast Cancer
411 Patients Enrolled for Breast Cancer

Eligibility Criteria

Age 18 - 59 · All Participants · 43 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
There is no specific restriction related to biologic therapy.
The details about chemotherapy will be explained in the disease characteristics section.
There are no specific surgical requirements or restrictions for participation in the study.
There are no requirements regarding menopause status.
There is no requirement for a specific life expectancy.
You have not been diagnosed with heart valve problems or irregular heartbeat in the past.
You have not had a serious mental health condition that affects your ability to function.
You do not have any other issues affecting your central nervous system.

Frequently Asked Questions

Are individuals over the age of sixty eligible to participate in this clinical trial?

"According to the stated restrictions, individuals must be between 18-59 years of age in order to qualify for this medical trial." - Anonymous Online Contributor

Unverified Answer

Has filgrastim received authorization from the FDA?

"As this is only a Phase 1 trial, which lacks evidence of safety and efficacy according to our team at Power, filgrastim received the lowest score possible-1." - Anonymous Online Contributor

Unverified Answer

Is this experiment novel or has it been conducted before?

"Since its initial study in 1997, sponsored by Alfacell and involving 300 participants, filgrastim has enjoyed a remarkable amount of research. Presently there are 1759 active studies conducted across 3488 cities and 82 countries concerning this medication's efficacy. Following the first trial in '97, it was granted Phase 3 drug approval." - Anonymous Online Contributor

Unverified Answer

Are there still opportunities to participate in this research?

"Per the website, this particular medical trial is no longer in need of participants; its initial posting was on May 18th 1999 and it's been updated as recently as February 17th 2022. Despite that, there are still 4359 other trials actively recruiting at this time." - Anonymous Online Contributor

Unverified Answer

To whom is enrollment in this study available?

"This medical trial is searching for 15 individuals with [breast cancer](, aged 18 to 59 years-old. It is essential that they meet the following criteria: Disease Characteristics - histologically verified instance of Stage IV metastatic cancer responding well to prior chemotherapy or high risk primary disease; Patient Characteristics - between eighteen and fifty nine, Karnofsky Performance Status 80%-100%; Life expectancy not specified; Hematopoietic/Hepatic/Renal parameters as noted in above text; Cardiovascular no prior valvular heart illness or arrhythmia; Pulmonary conditions according to given information. Additionally, applicants must have completed" - Anonymous Online Contributor

Unverified Answer

What medical conditions typically reap the benefits of filgrastim?

"filgrastim is frequently utilized for the management of leukemia, but can also be efficacious in treating metastatic bladder cancer and non-small cell lung cancers." - Anonymous Online Contributor

Unverified Answer

What is the current sample size for this research endeavor?

"This research trial is not currently accepting patients. Initially posted on May 18th, 1999 and last modified February 17th 2022, it cannot be used to join a study at this time. Alternatives can be found through 2600 studies that admit participants with breast cancer or the 1759 trials actively recruiting for filgrastim treatments." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.