Ignite Creation Date:
2025-12-24 @ 9:39 PM
Ignite Modification Date:
2025-12-26 @ 11:46 AM
Study NCT ID:
NCT01293032
Status:
COMPLETED
Last Update Posted:
2016-07-12
First Post:
2011-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Hormone Therapy Or Chemotherapy Before Surgery Based on Gene Expression Analysis in Treating Patients With Breast Cancer
Sponsor:
Virginia Commonwealth University
Organization:
Study Overview
Official Title:
Choosing Neoadjuvant Chemotherapy Versus Hormonal Therapy for Breast Cancer Based on Gene Expression Profile
Status:
COMPLETED
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This randomized pilot clinical trial studied whether the Oncotype DX gene expression "Recurrence Score" (RS) would be useful for helping make a decision about which type of pre-operative treatment, hormone therapy or chemotherapy would be a better for patients with hormone responsive cancers that were not suitable for breast conserving surgery. The RS is currently used to predict the risk of distant recurrence and the benefit of the addition of chemotherapy to hormonal therapy in the adjuvant setting.
Detailed Description:
Assessed the feasibility of carrying out a large-scale multi-center trial in which recurrence score (RS) was used to select treatment type in the neoadjuvant setting. Whether patients with intermediate RS were willing to be randomized between hormonal and chemotherapy.
The treatment received was not experimental and considered standard treatment for the type of cancer the participants had. What was experimental included the way in which they were assigned to a type of treatment. The design of this study was used to help determine if RS can be used to predict which type of treatment women with breast cancer are most likely to benefit from.
OUTLINE: Patients are assigned to 1 of 3 groups based on RS following Oncotype Dx gene expression profiling.
* GROUP 1 (RS \< 11): Patients receive neoadjuvant hormonal therapy comprising tamoxifen (pre-menopausal women) or an aromatase inhibitor (post-menopausal women) for 4-6 months in the absence of disease progression or unacceptable toxicity.
* GROUP 2 (RS 11-25): Patients are randomized to 1 of 2 treatment arms:
* ARM 1: Patients receive neoadjuvant hormonal therapy as in group I.
* ARM 2: Patients receive 6-8 courses of neoadjuvant chemotherapy comprising an anthracycline/taxane based regimen over 4-6 months in the absence of disease progression or unacceptable toxicity.
* GROUP 3 (RS \> 25): Patients receive neoadjuvant chemotherapy as in group 2 arm 2.
All patients undergo surgery and receive hormonal therapy for at least 5 years.
After completion of study treatment, patients are followed up periodically.
The treatment received was not experimental and considered standard treatment for the type of cancer the participants had. What was experimental included the way in which they were assigned to a type of treatment. The design of this study was used to help determine if RS can be used to predict which type of treatment women with breast cancer are most likely to benefit from.
OUTLINE: Patients are assigned to 1 of 3 groups based on RS following Oncotype Dx gene expression profiling.
* GROUP 1 (RS \< 11): Patients receive neoadjuvant hormonal therapy comprising tamoxifen (pre-menopausal women) or an aromatase inhibitor (post-menopausal women) for 4-6 months in the absence of disease progression or unacceptable toxicity.
* GROUP 2 (RS 11-25): Patients are randomized to 1 of 2 treatment arms:
* ARM 1: Patients receive neoadjuvant hormonal therapy as in group I.
* ARM 2: Patients receive 6-8 courses of neoadjuvant chemotherapy comprising an anthracycline/taxane based regimen over 4-6 months in the absence of disease progression or unacceptable toxicity.
* GROUP 3 (RS \> 25): Patients receive neoadjuvant chemotherapy as in group 2 arm 2.
All patients undergo surgery and receive hormonal therapy for at least 5 years.
After completion of study treatment, patients are followed up periodically.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2010-02342 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| P30CA016059 | NIH | None | https://reporter.nih.gov/quic… | View |