Clinical trial NCT01293032
Conditions: Ductal Breast Carcinoma in Situ Lobular Breast Carcinoma in Situ Stage II Breast Cancer Stage IIA Breast Cancer Stage IIB Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer
Keywords: Estrogen Receptor Positive Progesterone Receptor Positive HER2/Neu Negative Breast Cancer
Sponsor: Virginia Commonwealth University
Start date: 2011-04-01; Completion date: 2016-03-01
Enrollment: 59 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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.

Arms: arm 1: Patients with a Recurrence Score (RS) less than 11 (RS \<11) are assigned to Group 1, neoadjuvant hormonal therapy either tamoxifen (pre-menopausal women) or an aromatase inhibitor (post-menopausal women) for 4-6 months in the absence of disease progression or unacceptable toxicity.

Treatment:

* Neoadjuvant therapy
* Therapeutic conventional surgery
* Laboratory biomarker analysis/Correlative studies
* Gene Expression Analysis/ Oncotype DX Gene Expression Profiling System
* Hormonal therapy:

  * Tamoxifen Citrate (pre-menopausal women) OR
  * Aromatase Inhibition Therapy (post-menopausal women) arm 2: Patients with an intermediate RS (11-25) assigned to Group 2. Randomized to Arm 1, neoadjuvant hormonal therapy as in Group 1.

Treatment:

* Neoadjuvant therapy
* Therapeutic conventional surgery
* Laboratory biomarker analysis/Correlative studies
* Gene Expression Analysis/ Oncotype DX Gene Expression Profiling System
* Hormonal therapy:

  * Tamoxifen Citrate (pre-menopausal women) OR
  * Aromatase Inhibition Therapy (post-menopausal women) arm 3: Patients with an intermediate RS(11-25) assigned to Group 2. Randomized to Arm 2, neoadjuvant chemotherapy 6-8 courses of anthracycline/taxane based regimen over 4-6 months in the absence of disease progression or unacceptable toxicity.

Treatment:

* Neoadjuvant therapy
* Therapeutic conventional surgery
* Laboratory biomarker analysis/Correlative studies
* Gene Expression Analysis/Oncotype DX Gene Expression Profiling System
* Systemic chemotherapy arm 4: Patients with a high RS (\> 25) assigned to Group 3, neoadjuvant chemotherapy as in Group 2 Arm 2.

Treatment:

* Neoadjuvant therapy
* Therapeutic conventional surgery
* Laboratory biomarker analysis/Correlative studies
* Gene Expression Analysis/Oncotype DX Gene Expression Profiling System
* Systemic chemotherapy
Interventions: intervention 1: Neoadjuvant Therapy intervention 2: Therapeutic Conventional Surgery intervention 3: Laboratory Biomarker Analysis intervention 4: Gene Expression Analysis intervention 5: Systemic Chemotherapy intervention 6: Tamoxifen Citrate intervention 7: Aromatase Inhibition Therapy
Intervention descriptions: intervention 1: Undergo neoadjuvant therapy intervention 2: Undergo therapeutic conventional surgery intervention 3: Correlative studies intervention 4: Undergo Oncotype Dx gene expression profiling. The Oncotype DX gene expression profiling system will be used to calculate a "Recurrence Score" (RS). intervention 5: Undergo chemotherapy intervention 6: Undergo hormonal therapy intervention 7: Undergo hormonal therapy

Protocol documents: