Hormone Therapy Or Chemotherapy Before Surgery Based on Gene Expression Analysis in Treating Patients With Breast Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group 1 (RS < 11) 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) |
Procedure: Neoadjuvant Therapy
Undergo neoadjuvant therapy
Other Names:
Procedure: Therapeutic Conventional Surgery
Undergo therapeutic conventional surgery
Other: Laboratory Biomarker Analysis
Correlative studies
Other Names:
Genetic: Gene Expression Analysis
Undergo Oncotype Dx gene expression profiling. The Oncotype DX gene expression profiling system will be used to calculate a "Recurrence Score" (RS).
Drug: Tamoxifen Citrate
Undergo hormonal therapy
Other Names:
Drug: Aromatase Inhibition Therapy
Undergo hormonal therapy
Other Names:
|
| Experimental: Group 2 Arm 1 (RS 11-25) 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) |
Procedure: Neoadjuvant Therapy
Undergo neoadjuvant therapy
Other Names:
Procedure: Therapeutic Conventional Surgery
Undergo therapeutic conventional surgery
Other: Laboratory Biomarker Analysis
Correlative studies
Other Names:
Genetic: Gene Expression Analysis
Undergo Oncotype Dx gene expression profiling. The Oncotype DX gene expression profiling system will be used to calculate a "Recurrence Score" (RS).
Drug: Tamoxifen Citrate
Undergo hormonal therapy
Other Names:
Drug: Aromatase Inhibition Therapy
Undergo hormonal therapy
Other Names:
|
| Experimental: Group 2 Arm 2 (RS 11-25) 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 |
Procedure: Neoadjuvant Therapy
Undergo neoadjuvant therapy
Other Names:
Procedure: Therapeutic Conventional Surgery
Undergo therapeutic conventional surgery
Other: Laboratory Biomarker Analysis
Correlative studies
Other Names:
Genetic: Gene Expression Analysis
Undergo Oncotype Dx gene expression profiling. The Oncotype DX gene expression profiling system will be used to calculate a "Recurrence Score" (RS).
Drug: Systemic Chemotherapy
Undergo chemotherapy
|
| Experimental: Group 3 (RS > 25) 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 |
Procedure: Neoadjuvant Therapy
Undergo neoadjuvant therapy
Other Names:
Procedure: Therapeutic Conventional Surgery
Undergo therapeutic conventional surgery
Other: Laboratory Biomarker Analysis
Correlative studies
Other Names:
Genetic: Gene Expression Analysis
Undergo Oncotype Dx gene expression profiling. The Oncotype DX gene expression profiling system will be used to calculate a "Recurrence Score" (RS).
Drug: Systemic Chemotherapy
Undergo chemotherapy
|
Outcome Measures
Primary Outcome Measures
- The Proportion of Patients With RS 11-25 Who Refused the Assigned Treatment [Up to 2 years]
The primary purpose of this trial is to determine the feasibility of carrying out a large multi-center trial with a similar design. Feasibility, in terms of less than 1/3 of patients with intermediate (11-25) Recurrence Score (RS) who refused the assigned treatment (Group 2) or refused randomization between hormonal (Arm 1) or chemotherapy (Arm 2). The confidence interval will be 95%. The proportion (and 95% confidence interval) of patients with RS 11-25 who refuse the assigned treatment will be calculated.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
The treating surgeon must determine that breast conservation therapy (BCT) would be made more feasible by reducing tumor size using neoadjuvant systemic therapy
-
The patient must have signed and dated an institutional review board (IRB) approved consent form that conforms to federal and institutional guidelines
-
The patient must be female
-
The patient must be greater than or equal to 18 years old
-
The patient must have an Eastern Cooperative Oncology Group Score (ECOG) performance status of 0 or 1
-
The diagnosis of invasive carcinoma of the breast must have been made by core needle biopsy
-
The primary breast tumor must be >= 2 cm by physical exam or imaging
-
Ipsilateral axillary lymph nodes must be evaluated by imaging (MRI or ultrasound) within 6 weeks prior to randomization; If indicated for abnormal lymph nodes, fine needle aspirate (FNA) or core biopsy must be performed.
-
The tumor must have been determined to be HER2-negative as follows:
-
Fluorescent in situ hybridization (FISH)-negative (defined by ratio of HER2 to Chromosome 17 centromere (CEP17) must be < 2.2) or, if a ratio was not performed, the HER2 gene copy number must be < 4 per nucleus; or
-
Chromogenic in situ hybridization (CISH) is performed, the result must indicate a HER2 gene copy number of < 6 per nucleus; or
-
Immunohistochemistry (IHC) 0-1+; or
-
IHC 2+ and FISH-negative or CISH-negative
-
The tumor must have been determined to be ER+ and/or progesterone positive (PgR+) defined as > 10% tumor staining by immunohistochemistry
-
The patient must have been evaluated by a treating physician, reviewed and discussed by the multi-disciplinary breast team, and considered to be a candidate for chemotherapy
Exclusion Criteria:
-
FNA alone to diagnose the primary tumor
-
Excisional biopsy or lumpectomy performed prior to randomization
-
Surgical axillary staging procedure or sentinel node (SN) biopsy performed prior to registration
-
Tumors clinically staged as including inflammatory breast cancer
-
Ipsilateral cN2b or cN3 disease (patients with cN1 or cN2a disease are eligible)
-
Definitive clinical or radiologic evidence of metastatic disease (Note: chest imaging [mandatory for all patients] and other imaging [if required] must have been performed within 6 weeks prior to randomization)
-
Synchronous or metachronous contralateral invasive breast cancer; (patients with synchronous and/or metachronous contralateral ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) are eligible)
-
HER2 test result of IHC 3+, regardless of FISH results, if performed
-
Any history of ipsilateral invasive breast cancer or ipsilateral DCIS if treated with radiation therapy (RT); (patients with synchronous or metachronous ipsilateral LCIS are eligible)
-
History of non-breast malignancies, except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin, within 5 years prior to randomization
-
Treatment including RT, chemotherapy, and/or targeted therapy for the currently diagnosed breast cancer prior to registration
-
Cardiac disease (history of and/or active disease) that would preclude the use of chemotherapy
-
Pregnancy or lactation at the time of randomization; (Note: pregnancy testing must be performed within 2 weeks prior to randomization for women of childbearing potential)
-
Other non-malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up
-
Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements
-
Use of any investigational product within 30 days prior to registration
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Washington Cancer Institute | Washington | District of Columbia | United States | 20010 |
| 2 | Carolinas Medical Center | Charlotte | North Carolina | United States | 28203 |
| 3 | Forsyth Regional Cancer Center | Charlotte | North Carolina | United States | 28204 |
| 4 | Cone Health Cancer Center | Greensboro | North Carolina | United States | 27403 |
| 5 | Methodist Cancer Center | Houston | Texas | United States | 77030 |
| 6 | Lynchburg Hematology Oncology Clinic, Inc | Lynchburg | Virginia | United States | 24501 |
| 7 | Virginia Commonwealth University | Richmond | Virginia | United States | 23298 |
| 8 | Centre Hospitalier de l'Université de Montréal , Hôtel-Dieu Hospital | Montreal | Quebec | Canada | H2W 1T8 |
Sponsors and Collaborators
- Virginia Commonwealth University
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Harry D. Bear, MD, PhD, Virginia Commonwealth University
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- MCC-13311
- NCI-2010-02342
- P30CA016059
Study Results
Participant Flow
| Recruitment Details | Once a patient consented to this study and was deemed eligible the core biopsy blocks or slides were sent to obtain the Oncotype DX Breast Cancer Assay. After the Recurrence Score(RS) results were available the subject was assigned to Group 1, 2, or 3. If assigned to Group 2 they were randomized to Arm 1 or Arm 2. |
|---|---|
| Pre-assignment Detail | 5/64 subjects were not assigned or randomized to an arm: delayed oncotype result, core block lost, discrepancy in a bio-marker test, and two subjects deemed not eligible. There were 5 subjects who refused assigned randomization Group 2 Arm 2. 2/5 subjects who refused Group 2 Arm 2 were treated and evaluable for response on Arm 1. |
| Arm/Group Title | Group 1 (RS < 11) | Group 2 Arm 1 (RS 11-25) | Group 2 Arm 2 (RS 11-25) | Group 3 (RS > 25) |
|---|---|---|---|---|
| Arm/Group Description | Patients with a RS of less than 11 were assigned to Group 1. They received neoadjuvant hormonal therapy comprised of 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) | Patients with an intermediate RS (11-25) were assigned to Group 2. If randomized to Arm 1 they received 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) | Patients with an intermediate RS (11-25) were assigned to Group 2. If randomized to Arm 2 they received 6-8 courses of neoadjuvant chemotherapy comprised 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 | Patients with a high RS (> 25) were assigned to Group 3. They received chemotherapy, 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 |
| Period Title: Recurrence Score(RS)Assigned/Randomized | ||||
| STARTED | 12 | 17 | 16 | 14 |
| Assigned/Randomized to Arm | 12 | 17 | 16 | 14 |
| COMPLETED | 12 | 17 | 11 | 14 |
| NOT COMPLETED | 0 | 0 | 5 | 0 |
| Period Title: Recurrence Score(RS)Assigned/Randomized | ||||
| STARTED | 12 | 19 | 11 | 14 |
| COMPLETED | 10 | 14 | 10 | 13 |
| NOT COMPLETED | 2 | 5 | 1 | 1 |
Baseline Characteristics
| Arm/Group Title | Group 1 (RS < 11) | Group 2 Arm 1 (RS 11-25) | Group 2 Arm 2 (RS 11-25) | Group 3 (RS > 25) | Total |
|---|---|---|---|---|---|
| Arm/Group Description | Patients with a Recurrence Score (RS) of less than 11 were assigned to Group 1. They received neoadjuvant hormonal therapy comprised of 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) | Patients with an intermediate RS (11-25) were assigned to Group 2. If randomized to Arm 1 they received 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) | Patients with an intermediate RS (11-25) were assigned to Group 2. If randomized to Arm 2 they received 6-8 courses of neoadjuvant chemotherapy comprised 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 | Patients with a high RS (> 25) were assigned to Group 3. They received chemotherapy, 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 | Total of all reporting groups |
| Overall Participants | 12 | 17 | 16 | 14 | 59 |
| Age (Count of Participants) | |||||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
5
41.7%
|
8
47.1%
|
13
81.3%
|
10
71.4%
|
36
61%
|
| >=65 years |
7
58.3%
|
9
52.9%
|
3
18.8%
|
4
28.6%
|
23
39%
|
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
55.3125
(5.931426)
|
63.64706
(11.5539)
|
55.3125
(12.2556)
|
60.64286
(7.312867)
|
61.25423729
(10.52188724)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
12
100%
|
17
100%
|
16
100%
|
14
100%
|
59
100%
|
| Male |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||||
| Hispanic or Latino |
1
8.3%
|
0
0%
|
1
6.3%
|
0
0%
|
2
3.4%
|
| Not Hispanic or Latino |
11
91.7%
|
16
94.1%
|
15
93.8%
|
14
100%
|
56
94.9%
|
| Unknown or Not Reported |
0
0%
|
1
5.9%
|
0
0%
|
0
0%
|
1
1.7%
|
| Race (NIH/OMB) (Count of Participants) | |||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
5
41.7%
|
0
0%
|
4
25%
|
2
14.3%
|
11
18.6%
|
| White |
7
58.3%
|
17
100%
|
12
75%
|
12
85.7%
|
48
81.4%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | |||||
| Canada |
1
8.3%
|
4
23.5%
|
2
12.5%
|
4
28.6%
|
11
18.6%
|
| United States |
11
91.7%
|
13
76.5%
|
14
87.5%
|
10
71.4%
|
48
81.4%
|
Outcome Measures
| Title | The Proportion of Patients With RS 11-25 Who Refused the Assigned Treatment |
|---|---|
| Description | The primary purpose of this trial is to determine the feasibility of carrying out a large multi-center trial with a similar design. Feasibility, in terms of less than 1/3 of patients with intermediate (11-25) Recurrence Score (RS) who refused the assigned treatment (Group 2) or refused randomization between hormonal (Arm 1) or chemotherapy (Arm 2). The confidence interval will be 95%. The proportion (and 95% confidence interval) of patients with RS 11-25 who refuse the assigned treatment will be calculated. |
| Time Frame | Up to 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Patients with an intermediate RS(11-25) assigned to Group 2, Arm 1, and Arm 2 were combined in the analysis. |
| Arm/Group Title | Group 2 (RS 11-25) |
|---|---|
| Arm/Group Description | Patients with an intermediate RS (11-25) were assigned to Group 2. The subject was then randomized to treatment Arm 1, neoadjuvant hormonal therapy, or treatment Arm 2, neoadjuvant chemotherapy. |
| Measure Participants | 33 |
| Number (95% Confidence Interval) [proportion of participants] |
0.15
1.3%
|
Adverse Events
| Time Frame | ||||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Adverse events (AEs) that are a result of standard diagnosis and treatment are not being collected and should not be reported. | |||||||
| Arm/Group Title | Group 1 (RS < 11) | Group 2 Arm 1 (RS 11-25) | Group 2 Arm 2 (RS 11-25) | Group 3 (RS > 25) | ||||
| Arm/Group Description | Patients with a Recurrence Score (RS) of less than 11 were assigned to Group 1. They received neoadjuvant hormonal therapy comprised of 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) | Patients with an intermediate RS (11-25) were assigned to Group 2. If randomized to Arm 1 they received 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) | Patients with an intermediate RS (11-25) were assigned to Group 2. If randomized to Arm 2 they received 6-8 courses of neoadjuvant chemotherapy comprised 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 | Patients with a high RS (> 25) were assigned to Group 3. They received chemotherapy, 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 | ||||
All Cause Mortality |
||||||||
| Group 1 (RS < 11) | Group 2 Arm 1 (RS 11-25) | Group 2 Arm 2 (RS 11-25) | Group 3 (RS > 25) | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| Group 1 (RS < 11) | Group 2 Arm 1 (RS 11-25) | Group 2 Arm 2 (RS 11-25) | Group 3 (RS > 25) | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| Group 1 (RS < 11) | Group 2 Arm 1 (RS 11-25) | Group 2 Arm 2 (RS 11-25) | Group 3 (RS > 25) | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | ||||
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Harry D Bear, MD, PhD |
|---|---|
| Organization | Virginia Commonwealth University/Massey Cancer Center |
| Phone | 804-828-9325 |
| harry.bear@vcuhealth.org |
- MCC-13311
- NCI-2010-02342
- P30CA016059