Ignite Creation Date:
2024-05-05 @ 4:48 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00310180
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-27
First Post:
2006-03-29
Brief Title:
Hormone Therapy With or Without Combination Chemotherapy in Treating Women Who Have Undergone Surgery for Node-Negative Breast Cancer The TAILORx Trial
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Program for the Assessment of Clinical Cancer Tests PACCT-1 Trial Assigning Individualized Options for TreatmentThe TAILORx Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
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:
TAILORx
Brief Summary:
This randomized phase III trial studies the best individual therapy for women who have node-negative estrogen-receptor positive breast cancer by using a special test Oncotype DX and whether hormone therapy alone or hormone therapy together with combination chemotherapy is better for women who have an Oncotype DX recurrence score of 11-25 Estrogen can cause the growth of breast cancer cells Hormone therapy may fight breast cancer by blocking the use of estrogen by the tumor cells or by lowering the amount of estrogen the body makes Drugs used in chemotherapy work in different ways to stop the growth of tumor cells either by killing the cells by stopping them from dividing or by stopping them from spreading Giving hormone therapy together with more than one chemotherapy drug combination chemotherapy has been shown to reduce the chance of breast cancer recurrence but the benefit of adding chemotherapy to hormone therapy for women with node-negative estrogen-receptor positive breast cancer is small New tests may provide information about which patients are more likely to benefit from chemotherapy
Detailed Description:
PRIMARY OBJECTIVES
I To determine whether adjuvant hormonal therapy is not inferior to adjuvant chemohormonal in women whose tumors meet established clinical guidelines for adjuvant chemotherapy and fall in the primary study group category Oncotype DX Recurrence Score 11-25
II To create a tissue and specimen bank for patients enrolled in this trial including formalin fixed paraffin embedded tumor specimens tissue microarrays plasma and deoxyribonucleic acid DNA obtained from peripheral blood
SECONDARY OBJECTIVES
I To determine whether adjuvant hormonal therapy is sufficient treatment ie 10 year distant disease-free survival of at least 95 for women whose tumors meet established clinical guidelines for adjuvant chemotherapy and who fall into the Secondary Study Group-1 category Oncotype DX Recurrence Score 10
II To compare the outcomes projected at 10 years by Adjuvant with outcomes projected using classical pathologic information including tumor size hormone receptor status and histologic grade with those made by the Genomic Health Oncotype DX test Classical pathologic information and outcome results will also be used to create and refine models that would use classical information instead of or in combination with genomic tests
III To estimate failure rates as a function of recurrence score RS separately in the chemotherapy arms C D and no chemotherapy arms A B groups The purpose of the analysis is to develop more precise estimates of the relationship between recurrence score and chemotherapy treatment effect if any at the upper range of the RS 11 - 25 group
IV To determine the prognostic significance of the Oncotype DX recurrence score and of the individual RS gene groups proliferation gene group human epidermal growth factor receptor HER2 gene group estrogen receptor ER gene group invasion gene group and other genes
TERTIARY OBJECTIVES
I To evaluate the effects of chemotherapy and hormonal therapy vs hormonal therapy alone on perceived cognitive impairment fatigue fear of recurrence among pre-menopausal patients endocrine symptoms and sexual dysfunction and overall health-related quality of life HRQL
II To determine whether perceived cognitive impairment fatigue fear of recurrence endocrine symptoms and overall HRQL are similar for patients receiving chemotherapy plus hormonal therapy in secondary study group 2 as for those in the primary study group arm D vs C
III To determine whether perceived cognitive impairment fatigue fear of recurrence endocrine symptoms and overall HRQL are similar for patients receiving hormonal therapy alone in secondary study group 1 as for those in the primary study group arms A vs B
IV To determine whether age will be inversely associated with a fear of recurrence independent of treatment assignment
V Among participants receiving hormonal treatment alone on arm A and arm B to determine whether Oncotype DX Recurrence score will be inversely correlated with fear of recurrence
VI To create a biospecimen repository including plasma serum and CellSearch cassettes containing circulating tumor cells CTC for evaluating determinants of late relapse including candidate biomarkers reflecting occult tumor burden eg CTCs and plasma tumor DNA and host factors eg estrogen insulin growth factor-IGF axis inflammation etc
VII To create a biorepository of metastatic tumor samples in patients who have had a late relapse
VIII To determine body mass index BMI and comorbidity burden in patients with operable breast cancer five or more years after diagnosis
IX To determine whether there is a relationship between late relapse and BMI at diagnosis and at 5 years after diagnosis and whether BMI-associated inflammatory andor metabolic biomarkers are associated with early and late recurrence
OUTLINE This is a partially randomized study Patients are assigned to 1 of 3 treatment groups
GROUP 1 SECONDARY STUDY GROUP 1 ONCOTYPE DX RECURRENCE SCORE ODRS 10 Patients receive standard hormonal therapy eg tamoxifen alone orally PO aromatase inhibitor eg anastrozole letrozole or exemestane alone PO or tamoxifen PO followed by aromatase inhibitor PO at the discretion of the treating physician for 5 or 10 years
GROUP 2 PRIMARY STUDY GROUP ODRS 11-25 Patients are randomized to receive either hormonal therapy alone or combination chemotherapy and hormonal therapy
ARM I EXPERIMENTAL Patients receive hormonal therapy as in Group 1 at the discretion of the treating physician
ARM II STANDARD Patients receive standard combination chemotherapy at the discretion of the treating physician Within 4 weeks after the last dose of chemotherapy patients receive hormonal therapy as in Group 1 at the discretion of the treating physician
GROUP 3 SECONDARY STUDY GROUP 2 ODRS 26 Patients receive combination chemotherapy as in Group 2 Arm II followed by hormonal therapy as in Group 1
Patients in all groups who have had breast-conservation surgery are also treated with radiotherapy Radiotherapy should begin within 4 weeks of registration for patients receiving hormonal therapy alone or within 8 weeks after completion of chemotherapy Patients participating in National Surgical Adjuvant Breast and Bowel Project NSABP andor Radiation Therapy Oncology Group RTOG partial irradiation trials may receive partial breast radiation
After completion of study treatment patients are followed up every 3-6 months for 5 years and then annually for 15 years
I To determine whether adjuvant hormonal therapy is not inferior to adjuvant chemohormonal in women whose tumors meet established clinical guidelines for adjuvant chemotherapy and fall in the primary study group category Oncotype DX Recurrence Score 11-25
II To create a tissue and specimen bank for patients enrolled in this trial including formalin fixed paraffin embedded tumor specimens tissue microarrays plasma and deoxyribonucleic acid DNA obtained from peripheral blood
SECONDARY OBJECTIVES
I To determine whether adjuvant hormonal therapy is sufficient treatment ie 10 year distant disease-free survival of at least 95 for women whose tumors meet established clinical guidelines for adjuvant chemotherapy and who fall into the Secondary Study Group-1 category Oncotype DX Recurrence Score 10
II To compare the outcomes projected at 10 years by Adjuvant with outcomes projected using classical pathologic information including tumor size hormone receptor status and histologic grade with those made by the Genomic Health Oncotype DX test Classical pathologic information and outcome results will also be used to create and refine models that would use classical information instead of or in combination with genomic tests
III To estimate failure rates as a function of recurrence score RS separately in the chemotherapy arms C D and no chemotherapy arms A B groups The purpose of the analysis is to develop more precise estimates of the relationship between recurrence score and chemotherapy treatment effect if any at the upper range of the RS 11 - 25 group
IV To determine the prognostic significance of the Oncotype DX recurrence score and of the individual RS gene groups proliferation gene group human epidermal growth factor receptor HER2 gene group estrogen receptor ER gene group invasion gene group and other genes
TERTIARY OBJECTIVES
I To evaluate the effects of chemotherapy and hormonal therapy vs hormonal therapy alone on perceived cognitive impairment fatigue fear of recurrence among pre-menopausal patients endocrine symptoms and sexual dysfunction and overall health-related quality of life HRQL
II To determine whether perceived cognitive impairment fatigue fear of recurrence endocrine symptoms and overall HRQL are similar for patients receiving chemotherapy plus hormonal therapy in secondary study group 2 as for those in the primary study group arm D vs C
III To determine whether perceived cognitive impairment fatigue fear of recurrence endocrine symptoms and overall HRQL are similar for patients receiving hormonal therapy alone in secondary study group 1 as for those in the primary study group arms A vs B
IV To determine whether age will be inversely associated with a fear of recurrence independent of treatment assignment
V Among participants receiving hormonal treatment alone on arm A and arm B to determine whether Oncotype DX Recurrence score will be inversely correlated with fear of recurrence
VI To create a biospecimen repository including plasma serum and CellSearch cassettes containing circulating tumor cells CTC for evaluating determinants of late relapse including candidate biomarkers reflecting occult tumor burden eg CTCs and plasma tumor DNA and host factors eg estrogen insulin growth factor-IGF axis inflammation etc
VII To create a biorepository of metastatic tumor samples in patients who have had a late relapse
VIII To determine body mass index BMI and comorbidity burden in patients with operable breast cancer five or more years after diagnosis
IX To determine whether there is a relationship between late relapse and BMI at diagnosis and at 5 years after diagnosis and whether BMI-associated inflammatory andor metabolic biomarkers are associated with early and late recurrence
OUTLINE This is a partially randomized study Patients are assigned to 1 of 3 treatment groups
GROUP 1 SECONDARY STUDY GROUP 1 ONCOTYPE DX RECURRENCE SCORE ODRS 10 Patients receive standard hormonal therapy eg tamoxifen alone orally PO aromatase inhibitor eg anastrozole letrozole or exemestane alone PO or tamoxifen PO followed by aromatase inhibitor PO at the discretion of the treating physician for 5 or 10 years
GROUP 2 PRIMARY STUDY GROUP ODRS 11-25 Patients are randomized to receive either hormonal therapy alone or combination chemotherapy and hormonal therapy
ARM I EXPERIMENTAL Patients receive hormonal therapy as in Group 1 at the discretion of the treating physician
ARM II STANDARD Patients receive standard combination chemotherapy at the discretion of the treating physician Within 4 weeks after the last dose of chemotherapy patients receive hormonal therapy as in Group 1 at the discretion of the treating physician
GROUP 3 SECONDARY STUDY GROUP 2 ODRS 26 Patients receive combination chemotherapy as in Group 2 Arm II followed by hormonal therapy as in Group 1
Patients in all groups who have had breast-conservation surgery are also treated with radiotherapy Radiotherapy should begin within 4 weeks of registration for patients receiving hormonal therapy alone or within 8 weeks after completion of chemotherapy Patients participating in National Surgical Adjuvant Breast and Bowel Project NSABP andor Radiation Therapy Oncology Group RTOG partial irradiation trials may receive partial breast radiation
After completion of study treatment patients are followed up every 3-6 months for 5 years and then annually for 15 years
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10CA021115 | NIH | CTEP | httpsreporternihgovquickSearchU10CA021115 |
| NCI-2009-00707 | REGISTRY | None | None |
| ECOG-PACCT-1 | None | None | None |
| 06-482 | None | None | None |
| CDR0000472066 | None | None | None |
| PACCT-1 | None | None | None |
| PACCT-1 | OTHER | None | None |
| PACCT-1 | OTHER | None | None |
| U10CA180820 | NIH | None | None |