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Proteasome Inhibitor

Fulvestrant + Bortezomib for Estrogen Receptor Positive Breast Cancer

Phase 2
Waitlist Available
Led By Kerin B Adelson
Research Sponsored by National Cancer Institute (NCI)
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 up to 7 years
Awards & highlights

Study Summary

This trial compares fulvestrant with or without bortezomib in treating patients with estrogen receptor positive breast cancer.

Eligible Conditions
  • Metastatic Breast Cancer
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 7 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Progression Free Survival (PFS) at 12 Months
Number of Participants With Progression Free Survival (PFS) at 6 Months
Secondary outcome measures
Clinical Benefit Rate (CBR) of Adding Bortezomib to Fulvestrant in Arm C
Frequency of Most Common Toxicities
Number of Participants Who Survived Until Study End (up to 7 Years)
+1 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Arm C (fulvestrant, bortezomib)Experimental Treatment3 Interventions
Patients receive fulvestrant IV on day 1 and bortezomib IM on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group II: Arm B (fulvestrant, bortezomib)Experimental Treatment3 Interventions
Patients receive fulvestrant as in arm A and bortezomib IV on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group III: Arm A (fulvestrant)Experimental Treatment2 Interventions
Patients receive fulvestrant IM on day 1 (days -14, 1, and 15 of course 1 only). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may crossover to arm C.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bortezomib D-mannitol
FDA approved
Fulvestrant
FDA approved

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,657 Previous Clinical Trials
40,933,549 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
Kerin B AdelsonPrincipal InvestigatorMontefiore Medical Center - Moses Campus

Media Library

Bortezomib (Proteasome Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT01142401 — Phase 2
Breast Cancer Research Study Groups: Arm B (fulvestrant, bortezomib), Arm A (fulvestrant), Arm C (fulvestrant, bortezomib)
Breast Cancer Clinical Trial 2023: Bortezomib Highlights & Side Effects. Trial Name: NCT01142401 — Phase 2
Bortezomib (Proteasome Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01142401 — Phase 2

Frequently Asked Questions

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

What is the official stance of the FDA on Bortezomib?

"Given that this is a Phase 2 trial - meaning there is evidence of safety but none yet for efficacy - our team has given Bortezomib a score of 2."

Answered by AI

Are there any available slots left for participants in this clinical trial?

"As of now, this particular trial is not looking for new participants. It was originally posted on May 26th, 2010 and updated as recently as August 14th, 2020. However, there are 2373 trials actively recruiting patients with breast cancer and 285 trials involving Bortezomib that are currently seeking participants."

Answered by AI

Bortezomib is most often given to treat what condition?

"Bortezomib is a standard treatment for patients with the pik3ca gene mutation. It can also be used to manage malignant neoplasms, progression, disease, and mantle cell lymphoma (mcl)."

Answered by AI

How many people are currently taking part in this clinical trial?

"Unfortunately, this trial is no longer looking for participants. It was originally posted on May 26th, 2010 and most recently updated on August 14th, 2020. However, there are currently 2373 trials related to breast cancer recruiting patients as well as 285 Bortezomib clinical trials searching for volunteers."

Answered by AI

What other medical research has been conducted using Bortezomib?

"Bortezomib was first studied in 2004 at Lowell General Hospital. So far, there have been 1030 completed studies and 285 clinical trials are still recruiting patients. A significant number of these ongoing trials take place in Cleveland, Ohio."

Answered by AI

In how many different medical clinics is this research study being conducted currently?

"Case Western Reserve University in Cleveland, Ohio, Montefiore Medical Center-Einstein Campus in Bronx, New jersey, and Eastchester Center for Cancer Care in New Brunswick, Connecticut are managing this study alongside 21 other research centres."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Fulvestrant With or Without Bortezomib in Patients With Inoperable Locally Advanced or Metastatic Estrogen Receptor Positive Breast Cancer
2010. "Fulvestrant With or Without Bortezomib in Patients With Inoperable Locally Advanced or Metastatic Estrogen Receptor Positive Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01142401.
~8 spots leftby Apr 2025
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