Brief Summary
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Tamoxifen may fight breast cancer by blocking the use of estrogen. Anastrozole may fight breast cancer by decreasing estrogen production. It is not yet known whether anastrozole is more effective than tamoxifen in preventing the recurrence of breast cancer.
PURPOSE: This randomized phase III trial is studying anastrozole to see how well it works compared to tamoxifen in preventing the recurrence of breast cancer in postmenopausal women with ductal carcinoma in situ who are undergoing lumpectomy and radiation therapy.
PURPOSE: This randomized phase III trial is studying anastrozole to see how well it works compared to tamoxifen in preventing the recurrence of breast cancer in postmenopausal women with ductal carcinoma in situ who are undergoing lumpectomy and radiation therapy.
Brief Title
Anastrozole or Tamoxifen in Treating Postmenopausal Women With Ductal Carcinoma in Situ Who Are Undergoing Lumpectomy and Radiation Therapy
Detailed Description
OBJECTIVES:
* Compare the value of anastrozole vs tamoxifen, in terms of preventing recurrence (i.e., local, regional, and distant recurrences and contralateral breast cancer), after lumpectomy and radiotherapy in postmenopausal women with ductal carcinoma in situ (DCIS).
* Compare subsequent disease occurrence, in terms of invasive breast cancer (local, regional, distant, or contralateral), ipsilateral and contralateral breast cancer (invasive and DCIS), and non-breast second primary malignancies, in patients treated with these drugs.
* Compare quality of life and symptoms of patients treated with these drugs.\*
* Compare quality-adjusted survival time of patients treated with these drugs.\*
* Compare the occurrence of osteoporotic fractures in patients treated with these drugs.
* Compare disease-free and overall survival of patients treated with these drugs. NOTE: \*The quality of life study closed to accrual as of 12/28/04.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to age (under 60 vs 60 and over). Patients are randomized to 1 of 2 treatment arms (arm I and arm II closed to accrual as of 6/15/06).
* Arm I (closed to accrual as of 6/15/06): Patients receive oral tamoxifen and oral placebo once daily for 5 years.
* Arm II (closed to accrual as of 6/15/06): Patients receive oral anastrozole and oral placebo once daily for 5 years.
Beginning within 8 weeks of randomization, all patients also undergo whole breast radiotherapy, unless the patient is enrolled in protocol NSABP-B-39 and randomized to the partial breast irradiation group.
Patients are followed every 6 months for 5 years, and then annually thereafter.
For patients enrolled in the quality of life study, quality of life is assessed at baseline and then every 6 months for 6 years.\*
NOTE: \*The quality of life study closed to accrual as of 12/28/04.
PROJECTED ACCRUAL: A total of 3,000 patients (1,500 per treatment arm) will be accrued for this study within 5 years (arm I and arm II closed to accrual as of 6/15/06).
* Compare the value of anastrozole vs tamoxifen, in terms of preventing recurrence (i.e., local, regional, and distant recurrences and contralateral breast cancer), after lumpectomy and radiotherapy in postmenopausal women with ductal carcinoma in situ (DCIS).
* Compare subsequent disease occurrence, in terms of invasive breast cancer (local, regional, distant, or contralateral), ipsilateral and contralateral breast cancer (invasive and DCIS), and non-breast second primary malignancies, in patients treated with these drugs.
* Compare quality of life and symptoms of patients treated with these drugs.\*
* Compare quality-adjusted survival time of patients treated with these drugs.\*
* Compare the occurrence of osteoporotic fractures in patients treated with these drugs.
* Compare disease-free and overall survival of patients treated with these drugs. NOTE: \*The quality of life study closed to accrual as of 12/28/04.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to age (under 60 vs 60 and over). Patients are randomized to 1 of 2 treatment arms (arm I and arm II closed to accrual as of 6/15/06).
* Arm I (closed to accrual as of 6/15/06): Patients receive oral tamoxifen and oral placebo once daily for 5 years.
* Arm II (closed to accrual as of 6/15/06): Patients receive oral anastrozole and oral placebo once daily for 5 years.
Beginning within 8 weeks of randomization, all patients also undergo whole breast radiotherapy, unless the patient is enrolled in protocol NSABP-B-39 and randomized to the partial breast irradiation group.
Patients are followed every 6 months for 5 years, and then annually thereafter.
For patients enrolled in the quality of life study, quality of life is assessed at baseline and then every 6 months for 6 years.\*
NOTE: \*The quality of life study closed to accrual as of 12/28/04.
PROJECTED ACCRUAL: A total of 3,000 patients (1,500 per treatment arm) will be accrued for this study within 5 years (arm I and arm II closed to accrual as of 6/15/06).
Categories
Completion Date
Completion Date Type
Actual
Conditions
Breast Cancer
Eligibility Criteria
DISEASE CHARACTERISTICS:
* Histologically confirmed ductal carcinoma in situ (DCIS) of the breast
* Mixed DCIS and lobular carcinoma in situ (LCIS) allowed
* Must have undergone lumpectomy
* Margins must be histologically free of disease
* Re-excision to obtain tumor-free margins allowed
* No more than 84 days since prior lumpectomy or re-excision
* More than 1 area of DCIS allowed provided all disease is removed with tumor-free margins
* Masses or clusters of calcification that are clinically or mammographically suspicious must be biopsied
* No prior invasive breast cancer or DCIS
* Patients with a history of LCIS are eligible
* No prior or concurrent invasive (including microinvasive) breast cancer
* DCIS "suspicious" for microinvasion allowed
* No bilateral malignancy
* No mass or mammographic abnormality suspicious for malignancy in the opposite breast unless not malignant as proven by biopsy
* No Paget's disease of the nipple
* No positive ipsilateral axillary or intramammary nodes
* No palpable nodes in the ipsilateral or contralateral axilla or palpable supraclavicular or infraclavicular nodes unless not involved with tumor as proven by biopsy
* Hormone receptor status:
* Estrogen- or progesterone-receptor positive as determined by immunohistochemistry
* Borderline results are considered positive
PATIENT CHARACTERISTICS:
Age
* See Menopausal status
Sex:
* Female
Menopausal status:
* Postmenopausal as defined by at least 1 of the following:
* Prior documented bilateral oophorectomy
* At least 12 months without spontaneous bleeding
* Age 55 or over with prior hysterectomy without oophorectomy
* Age 54 or under with prior hysterectomy without oophorectomy with a documented follicle-stimulating hormone level in the postmenopausal range
Performance status
* Zubrod 0-2
Life expectancy
* At least 10 years (excluding diagnosis of breast cancer)
Hematopoietic
* WBC normal
Hepatic
* AST normal
* Bilirubin normal
* Alkaline phosphatase normal
* No hepatic disease that would preclude administration of study drugs
Renal
* Creatinine normal
* No renal disease that would preclude administration of study drugs
Cardiovascular
* No prior documented cerebral vascular accident or transient ischemic attack
* No prior deep vein thrombosis
* No cardiovascular disease that would preclude administration of study drugs
* No uncontrolled hypertension (i.e., systolic blood pressure at least 180 mm Hg or diastolic blood pressure at least 110 mm Hg based on the average of 2 or more readings at each of 2 or more visits after initial screening)
* No uncontrolled atrial fibrillation
Pulmonary
* No pulmonary embolus
Other
* Not pregnant or nursing
* Patients with a history of non-breast malignancies are eligible provided they have been disease-free for ≥ 5 years and are deemed by their physician to be at low risk for recurrence
* No other malignancy within the past 5 years except treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, carcinoma in situ of the colon, or melanoma in situ
* No psychiatric or addictive disorders that would preclude informed consent
* No uncontrolled diabetes, defined as hemoglobin A1C greater than 9% (fasting glucose 200 mg/dL)
* No nonmalignant systemic disease that would preclude administration of study drugs
PRIOR CONCURRENT THERAPY:
Endocrine therapy
* No prior or concurrent aromatase inhibitors (e.g., exemestane or letrozole) or tamoxifen
* No concurrent raloxifene or other selective estrogen receptor modulators
* No concurrent sex hormone therapy (e.g., estrogen or progesterone replacement therapy, oral contraceptives, androgens, luteinizing hormone releasing hormone analogs, prolactin inhibitors, or antiandrogens)
* Low-dose estrogen vaginal creams or Estring allowed
Radiotherapy
* Radiotherapy for this cancer initiated before study is allowed
Surgery
* See Disease Characteristics
* No prior or concurrent mastectomy for DCIS
* Prior sentinel node biopsy or axillary node dissection allowed provided nodes are pathologically negative
Other
* No concurrent warfarin
* No other systemic therapy for this cancer initiated before study
* No other concurrent anticancer therapy unless permitted by the protocol investigator
* No concurrent participation in another clinical trial of therapy for DCIS
* Concurrent participation in protocol NSABP-B-39 allowed
* Histologically confirmed ductal carcinoma in situ (DCIS) of the breast
* Mixed DCIS and lobular carcinoma in situ (LCIS) allowed
* Must have undergone lumpectomy
* Margins must be histologically free of disease
* Re-excision to obtain tumor-free margins allowed
* No more than 84 days since prior lumpectomy or re-excision
* More than 1 area of DCIS allowed provided all disease is removed with tumor-free margins
* Masses or clusters of calcification that are clinically or mammographically suspicious must be biopsied
* No prior invasive breast cancer or DCIS
* Patients with a history of LCIS are eligible
* No prior or concurrent invasive (including microinvasive) breast cancer
* DCIS "suspicious" for microinvasion allowed
* No bilateral malignancy
* No mass or mammographic abnormality suspicious for malignancy in the opposite breast unless not malignant as proven by biopsy
* No Paget's disease of the nipple
* No positive ipsilateral axillary or intramammary nodes
* No palpable nodes in the ipsilateral or contralateral axilla or palpable supraclavicular or infraclavicular nodes unless not involved with tumor as proven by biopsy
* Hormone receptor status:
* Estrogen- or progesterone-receptor positive as determined by immunohistochemistry
* Borderline results are considered positive
PATIENT CHARACTERISTICS:
Age
* See Menopausal status
Sex:
* Female
Menopausal status:
* Postmenopausal as defined by at least 1 of the following:
* Prior documented bilateral oophorectomy
* At least 12 months without spontaneous bleeding
* Age 55 or over with prior hysterectomy without oophorectomy
* Age 54 or under with prior hysterectomy without oophorectomy with a documented follicle-stimulating hormone level in the postmenopausal range
Performance status
* Zubrod 0-2
Life expectancy
* At least 10 years (excluding diagnosis of breast cancer)
Hematopoietic
* WBC normal
Hepatic
* AST normal
* Bilirubin normal
* Alkaline phosphatase normal
* No hepatic disease that would preclude administration of study drugs
Renal
* Creatinine normal
* No renal disease that would preclude administration of study drugs
Cardiovascular
* No prior documented cerebral vascular accident or transient ischemic attack
* No prior deep vein thrombosis
* No cardiovascular disease that would preclude administration of study drugs
* No uncontrolled hypertension (i.e., systolic blood pressure at least 180 mm Hg or diastolic blood pressure at least 110 mm Hg based on the average of 2 or more readings at each of 2 or more visits after initial screening)
* No uncontrolled atrial fibrillation
Pulmonary
* No pulmonary embolus
Other
* Not pregnant or nursing
* Patients with a history of non-breast malignancies are eligible provided they have been disease-free for ≥ 5 years and are deemed by their physician to be at low risk for recurrence
* No other malignancy within the past 5 years except treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, carcinoma in situ of the colon, or melanoma in situ
* No psychiatric or addictive disorders that would preclude informed consent
* No uncontrolled diabetes, defined as hemoglobin A1C greater than 9% (fasting glucose 200 mg/dL)
* No nonmalignant systemic disease that would preclude administration of study drugs
PRIOR CONCURRENT THERAPY:
Endocrine therapy
* No prior or concurrent aromatase inhibitors (e.g., exemestane or letrozole) or tamoxifen
* No concurrent raloxifene or other selective estrogen receptor modulators
* No concurrent sex hormone therapy (e.g., estrogen or progesterone replacement therapy, oral contraceptives, androgens, luteinizing hormone releasing hormone analogs, prolactin inhibitors, or antiandrogens)
* Low-dose estrogen vaginal creams or Estring allowed
Radiotherapy
* Radiotherapy for this cancer initiated before study is allowed
Surgery
* See Disease Characteristics
* No prior or concurrent mastectomy for DCIS
* Prior sentinel node biopsy or axillary node dissection allowed provided nodes are pathologically negative
Other
* No concurrent warfarin
* No other systemic therapy for this cancer initiated before study
* No other concurrent anticancer therapy unless permitted by the protocol investigator
* No concurrent participation in another clinical trial of therapy for DCIS
* Concurrent participation in protocol NSABP-B-39 allowed
Inclusion Criteria
DISEASE CHARACTERISTICS:
* Histologically confirmed ductal carcinoma in situ (DCIS) of the breast
* Mixed DCIS and lobular carcinoma in situ (LCIS) allowed
* Must have undergone lumpectomy
* Margins must be histologically free of disease
* Re-excision to obtain tumor-free margins allowed
* No more than 84 days since prior lumpectomy or re-excision
* More than 1 area of DCIS allowed provided all disease is removed with tumor-free margins
* Masses or clusters of calcification that are clinically or mammographically suspicious must be biopsied
* No prior invasive breast cancer or DCIS
* Patients with a history of LCIS are eligible
* No prior or concurrent invasive (including microinvasive) breast cancer
* DCIS "suspicious" for microinvasion allowed
* No bilateral malignancy
* No mass or mammographic abnormality suspicious for malignancy in the opposite breast unless not malignant as proven by biopsy
* No Paget's disease of the nipple
* No positive ipsilateral axillary or intramammary nodes
* No palpable nodes in the ipsilateral or contralateral axilla or palpable supraclavicular or infraclavicular nodes unless not involved with tumor as proven by biopsy
* Hormone receptor status:
* Estrogen- or progesterone-receptor positive as determined by immunohistochemistry
* Borderline results are considered positive
PATIENT CHARACTERISTICS:
Age
* See Menopausal status
Sex:
* Female
Menopausal status:
* Postmenopausal as defined by at least 1 of the following:
* Prior documented bilateral oophorectomy
* At least 12 months without spontaneous bleeding
* Age 55 or over with prior hysterectomy without oophorectomy
* Age 54 or under with prior hysterectomy without oophorectomy with a documented follicle-stimulating hormone level in the postmenopausal range
Performance status
* Zubrod 0-2
Life expectancy
* At least 10 years (excluding diagnosis of breast cancer)
Hematopoietic
* WBC normal
Hepatic
* AST normal
* Bilirubin normal
* Alkaline phosphatase normal
* No hepatic disease that would preclude administration of study drugs
Renal
* Creatinine normal
* No renal disease that would preclude administration of study drugs
Cardiovascular
* No prior documented cerebral vascular accident or transient ischemic attack
* No prior deep vein thrombosis
* No cardiovascular disease that would preclude administration of study drugs
* No uncontrolled hypertension (i.e., systolic blood pressure at least 180 mm Hg or diastolic blood pressure at least 110 mm Hg based on the average of 2 or more readings at each of 2 or more visits after initial screening)
* No uncontrolled atrial fibrillation
Pulmonary
* No pulmonary embolus
Other
* Not pregnant or nursing
* Patients with a history of non-breast malignancies are eligible provided they have been disease-free for ≥ 5 years and are deemed by their physician to be at low risk for recurrence
* No other malignancy within the past 5 years except treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, carcinoma in situ of the colon, or melanoma in situ
* No psychiatric or addictive disorders that would preclude informed consent
* No uncontrolled diabetes, defined as hemoglobin A1C greater than 9% (fasting glucose 200 mg/dL)
* No nonmalignant systemic disease that would preclude administration of study drugs
PRIOR CONCURRENT THERAPY:
Endocrine therapy
* No prior or concurrent aromatase inhibitors (e.g., exemestane or letrozole) or tamoxifen
* No concurrent raloxifene or other selective estrogen receptor modulators
* No concurrent sex hormone therapy (e.g., estrogen or progesterone replacement therapy, oral contraceptives, androgens, luteinizing hormone releasing hormone analogs, prolactin inhibitors, or antiandrogens)
* Low-dose estrogen vaginal creams or Estring allowed
Radiotherapy
* Radiotherapy for this cancer initiated before study is allowed
Surgery
* See Disease Characteristics
* No prior or concurrent mastectomy for DCIS
* Prior sentinel node biopsy or axillary node dissection allowed provided nodes are pathologically negative
Other
* No concurrent warfarin
* No other systemic therapy for this cancer initiated before study
* No other concurrent anticancer therapy unless permitted by the protocol investigator
* No concurrent participation in another clinical trial of therapy for DCIS
* Concurrent participation in protocol NSABP-B-39 allowed
* Histologically confirmed ductal carcinoma in situ (DCIS) of the breast
* Mixed DCIS and lobular carcinoma in situ (LCIS) allowed
* Must have undergone lumpectomy
* Margins must be histologically free of disease
* Re-excision to obtain tumor-free margins allowed
* No more than 84 days since prior lumpectomy or re-excision
* More than 1 area of DCIS allowed provided all disease is removed with tumor-free margins
* Masses or clusters of calcification that are clinically or mammographically suspicious must be biopsied
* No prior invasive breast cancer or DCIS
* Patients with a history of LCIS are eligible
* No prior or concurrent invasive (including microinvasive) breast cancer
* DCIS "suspicious" for microinvasion allowed
* No bilateral malignancy
* No mass or mammographic abnormality suspicious for malignancy in the opposite breast unless not malignant as proven by biopsy
* No Paget's disease of the nipple
* No positive ipsilateral axillary or intramammary nodes
* No palpable nodes in the ipsilateral or contralateral axilla or palpable supraclavicular or infraclavicular nodes unless not involved with tumor as proven by biopsy
* Hormone receptor status:
* Estrogen- or progesterone-receptor positive as determined by immunohistochemistry
* Borderline results are considered positive
PATIENT CHARACTERISTICS:
Age
* See Menopausal status
Sex:
* Female
Menopausal status:
* Postmenopausal as defined by at least 1 of the following:
* Prior documented bilateral oophorectomy
* At least 12 months without spontaneous bleeding
* Age 55 or over with prior hysterectomy without oophorectomy
* Age 54 or under with prior hysterectomy without oophorectomy with a documented follicle-stimulating hormone level in the postmenopausal range
Performance status
* Zubrod 0-2
Life expectancy
* At least 10 years (excluding diagnosis of breast cancer)
Hematopoietic
* WBC normal
Hepatic
* AST normal
* Bilirubin normal
* Alkaline phosphatase normal
* No hepatic disease that would preclude administration of study drugs
Renal
* Creatinine normal
* No renal disease that would preclude administration of study drugs
Cardiovascular
* No prior documented cerebral vascular accident or transient ischemic attack
* No prior deep vein thrombosis
* No cardiovascular disease that would preclude administration of study drugs
* No uncontrolled hypertension (i.e., systolic blood pressure at least 180 mm Hg or diastolic blood pressure at least 110 mm Hg based on the average of 2 or more readings at each of 2 or more visits after initial screening)
* No uncontrolled atrial fibrillation
Pulmonary
* No pulmonary embolus
Other
* Not pregnant or nursing
* Patients with a history of non-breast malignancies are eligible provided they have been disease-free for ≥ 5 years and are deemed by their physician to be at low risk for recurrence
* No other malignancy within the past 5 years except treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, carcinoma in situ of the colon, or melanoma in situ
* No psychiatric or addictive disorders that would preclude informed consent
* No uncontrolled diabetes, defined as hemoglobin A1C greater than 9% (fasting glucose 200 mg/dL)
* No nonmalignant systemic disease that would preclude administration of study drugs
PRIOR CONCURRENT THERAPY:
Endocrine therapy
* No prior or concurrent aromatase inhibitors (e.g., exemestane or letrozole) or tamoxifen
* No concurrent raloxifene or other selective estrogen receptor modulators
* No concurrent sex hormone therapy (e.g., estrogen or progesterone replacement therapy, oral contraceptives, androgens, luteinizing hormone releasing hormone analogs, prolactin inhibitors, or antiandrogens)
* Low-dose estrogen vaginal creams or Estring allowed
Radiotherapy
* Radiotherapy for this cancer initiated before study is allowed
Surgery
* See Disease Characteristics
* No prior or concurrent mastectomy for DCIS
* Prior sentinel node biopsy or axillary node dissection allowed provided nodes are pathologically negative
Other
* No concurrent warfarin
* No other systemic therapy for this cancer initiated before study
* No other concurrent anticancer therapy unless permitted by the protocol investigator
* No concurrent participation in another clinical trial of therapy for DCIS
* Concurrent participation in protocol NSABP-B-39 allowed
Gender
Female
Gender Based
false
Keywords
breast cancer in situ
ductal breast carcinoma in situ
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
NCT Id
NCT00053898
Org Class
Network
Org Full Name
NSABP Foundation Inc
Org Study Id
NSABP B-35
Overall Status
Completed
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Clinical Trial Comparing Anastrozole With Tamoxifen in Postmenopausal Patients With Ductal Carcinoma in Situ (DCIS) Undergoing Lumpectomy With Radiation Therapy
Primary Outcomes
Outcome Description
Percentage of patients free from breast cancer event at 10 years where events include local, regional, or distant recurrence or contralateral breast cancer, invasive or DCIS.
Outcome Measure
Percentage of Patients Free From Breast Cancer
Outcome Time Frame
10 years
Secondary Ids
Secondary Id
NSABP-B-35
Secondary Id
SWOG-NSABP-B-35
Secondary Id
NCCTG-NSABP-B-35
Secondary Id
ACOSOG-NSABP-B-35
Secondary Outcomes
Outcome Description
Percentage of patients free from an invasive breast cancer event where events include invasive local, regional, or distant recurrence, or contralateral breast cancer, occurring as a first cancer event. Note that this endpoint includes only invasive breast cancers and the primary endpoint includes both invasive and DCIS breast cancers.
Outcome Time Frame
10 years
Outcome Measure
Percentage of Patients Free From Invasive Breast Cancer
Outcome Description
Percentage of patients free from a breast cancer recurrence in the ipsilateral breast (invasive and DCIS), occurring as a first cancer event.
Outcome Time Frame
10 years
Outcome Measure
Percentage of Patients Free From Ipsilateral Recurrence
Outcome Description
Percentage of patients free from a breast cancer recurrence in the contralateral breast (invasive and DCIS), occurring as a first cancer event.
Outcome Time Frame
10 years
Outcome Measure
Percentage of Patients Free From Contralateral Breast Cancer
Outcome Description
Percentage of patients free from any non-breast second primary cancer other than squamous or basal cell carcinoma of the skin, carcinoma in situ of the colon, melanoma in situ, or carcinoma in situ of the cervix, occurring as a first cancer event.
Outcome Time Frame
10 years
Outcome Measure
Percentage of Patients Free From Non-breast Secondary Cancer
Outcome Description
Percentage of patients free from fractures of the hip, spine, and wrist.
Outcome Time Frame
10 years
Outcome Measure
Percentage of Patients Free From Osteoporotic Fractures
Outcome Description
Percentage of patients free from a disease-free survival event where events include any recurrence, second primary cancer, and death from any cause. Lobular carcinoma in situ (LCIS), basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the colon, melanoma in situ, and cervical carcinoma in situ will not be included as recurrences or second primary cancer.
Outcome Time Frame
10 years
Outcome Measure
Percentage of Patients Alive and Disease-free
Outcome Description
Percentage of patients alive.
Outcome Time Frame
10 years
Outcome Measure
Percentage of Patients Alive (Overall Survival)
Outcome Description
The primary outcome of the QOL substudy was the Medical Outcomes Study-Short Form 12 (SF-12) physical health component scale score. The SF-12 physical score was calculated to have a range of 0-100 and was normalized to have a mean of 50 and a standard deviation of 10 in the general population. Higher scores indicate better health.
Outcome Time Frame
5 years
Outcome Measure
Quality of Life-Short Form 12 (SF-12) Physical Health Component Score
Outcome Description
The mean quality-adjusted survival time (in months) in each treatment group, estimated by the Quality-Adjusted Time without Symptoms and Toxicity (Q-TWIST) method.
Outcome Time Frame
10 years
Outcome Measure
Quality-adjusted Survival Time
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Child
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
0
Investigators
Investigator Type
Principal Investigator
Investigator Name
Joseph Sparano
Investigator Email
jsparano@montefiore.org
Investigator Phone
718-405-8404