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Alkylating agent

Weekly Paclitaxel for Breast Cancer (FB-12 Trial)

Phase 2
Recruiting
Led By Norman Wolmark, MD
Research Sponsored by NSABP Foundation Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from initiation of study therapy to time of surgery, which is usually performed 3 to 4 weeks after completion of study therapy
Awards & highlights

FB-12 Trial Summary

This trial will test whether neoadjuvant chemotherapy with anti-HER2 antibodies is effective in patients with HER2-negative invasive breast cancer who have abnormal HER2 signaling activity.

Eligible Conditions
  • HER2-negative Breast Cancer

FB-12 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from initiation of study therapy to time of surgery, which is usually performed 3 to 4 weeks after completion of study therapy
This trial's timeline: 3 weeks for screening, Varies for treatment, and from initiation of study therapy to time of surgery, which is usually performed 3 to 4 weeks after completion of study therapy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pathologic complete response (PCR) to study therapy (both breast and lymph node-combined; ypT0/Tis ypN0)
Secondary outcome measures
Clinical complete response (both breast and axilla)
Frequency of adverse events assessed by CTCAE 4.0
Logistic regression
+2 more

FB-12 Trial Design

1Treatment groups
Experimental Treatment
Group I: Arm 1Experimental Treatment6 Interventions
Celcuity CELx HSF Test on tumor material obtained from research core biopsy to select patients with abnormal HER2 signaling tumors Doxorubicin + cyclophosphamide followed by Weekly Paclitaxel +Trastuzumab+Pertuzumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Doxorubicin
2012
Completed Phase 3
~7940
Weekly Paclitaxel
2016
Completed Phase 3
~250
Cyclophosphamide
1995
Completed Phase 3
~3780
Trastuzumab
2014
Completed Phase 4
~5190
Pertuzumab
2014
Completed Phase 3
~7500

Find a Location

Who is running the clinical trial?

NSABP Foundation IncLead Sponsor
86 Previous Clinical Trials
136,924 Total Patients Enrolled
45 Trials studying Breast Cancer
100,530 Patients Enrolled for Breast Cancer
Genentech, Inc.Industry Sponsor
1,538 Previous Clinical Trials
567,616 Total Patients Enrolled
97 Trials studying Breast Cancer
23,218 Patients Enrolled for Breast Cancer
Celcuity, LLCIndustry Sponsor

Media Library

Cyclophosphamide (Alkylating agent) Clinical Trial Eligibility Overview. Trial Name: NCT03412643 — Phase 2
Breast Cancer Research Study Groups: Arm 1
Breast Cancer Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT03412643 — Phase 2
Cyclophosphamide (Alkylating agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03412643 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any regulatory clearances for Weekly Paclitaxel?

"While there is some evidence of safety, no data exists yet to prove efficacy. Thus, the team at Power assigned Weekly Paclitaxel a score of 2 on its scale from 1-3."

Answered by AI

Are there any existing investigations that have involved the use of Weekly Paclitaxel?

"At present, 1825 clinical trials for Weekly Paclitaxel have been launched, with 408 of those being in Phase 3. These studies are mainly conducted within Seattle, Washington but encompass 77104 different sites."

Answered by AI

Is enrollment into this experiment open to contributors?

"Investigational data on clinicaltrials.gov states that this trial is actively recruiting participants, with the original posting having been made on May 14th 2018 and last edited on May 31st 2022."

Answered by AI

What are the primary maladies that Weekly Paclitaxel is applied to address?

"Weekly Paclitaxel has been observed to be an effective form of treatment for cyclophosphamide, Kaposi's sarcoma AIDS related and leukemia."

Answered by AI

Is this the inaugural endeavor of its type?

"Since 1997, Weekly Paclitaxel has been studied extensively. A sponsored clinical trial by Alfacell in the same year determined its efficacy and granted it Phase 3 drug approval. At present, there are 1825 active trials for this medication conducted across 3704 cities and 82 countries worldwide."

Answered by AI

How many health centers are currently engaged in this clinical trial?

"This trial is currently acquiring participants from 43 different medical centres, located in Newark, Zanesville and York as well as other cities. It would be prudent to choose the closest site so that travelling demands are at a minimum if you decide to take part."

Answered by AI

What is the uppermost capacity for the number of participants in this trial?

"This clinical trial is in need of 64 participants that meet the pre-determined selection criteria. These individuals may take part at either Licking Memorial Hospital, located in Newark Pennsylvania or Genesis Health Care situated in Zanesville Michigan."

Answered by AI
~9 spots leftby Mar 2025