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c3257f7b-f5b4-4a9c-8a8f-b037f27caa8f | Recently confirmed unilateral ductal carcinoma in situ or invasive cancer of the breast Candidates for the primary trial must have a life expectancy over 6 months. | 0 |
c3257f7b-f5b4-4a9c-8a8f-b037f27caa8f | Confirmed by biopsy or fine needle aspiration (FNA) within the past 60 days Candidates for the primary trial must have a life expectancy over 6 months. | 0 |
c3257f7b-f5b4-4a9c-8a8f-b037f27caa8f | Negative or benign mammogram (BI-RADS assessment 1 or 2) and negative or benign clinical breast exam of the contralateral breast within the past 90 days Candidates for the primary trial must have a life expectancy over 6 months. | 0 |
c3257f7b-f5b4-4a9c-8a8f-b037f27caa8f | Prior biopsy of the contralateral breast (including FNA) is allowed provided it was performed at least 6 months prior to study entry Candidates for the primary trial must have a life expectancy over 6 months. | 0 |
c3257f7b-f5b4-4a9c-8a8f-b037f27caa8f | Prior magnetic resonance exam of the contralateral breast is allowed provided it was performed at least 1 year prior to study entry Candidates for the primary trial must have a life expectancy over 6 months. | 0 |
c3257f7b-f5b4-4a9c-8a8f-b037f27caa8f | No remote history of breast cancer Candidates for the primary trial must have a life expectancy over 6 months. | 0 |
c3257f7b-f5b4-4a9c-8a8f-b037f27caa8f | No new breast symptoms within the past 60 days for which further evaluation is recommended Candidates for the primary trial must have a life expectancy over 6 months. | 0 |
c3257f7b-f5b4-4a9c-8a8f-b037f27caa8f | Hormone receptor status: Candidates for the primary trial must have a life expectancy over 6 months. | 0 |
c3257f7b-f5b4-4a9c-8a8f-b037f27caa8f | Not specified Candidates for the primary trial must have a life expectancy over 6 months. | 0 |
c3257f7b-f5b4-4a9c-8a8f-b037f27caa8f | PATIENT CHARACTERISTICS: Candidates for the primary trial must have a life expectancy over 6 months. | 0 |
c3257f7b-f5b4-4a9c-8a8f-b037f27caa8f | Age Candidates for the primary trial must have a life expectancy over 6 months. | 0 |
c3257f7b-f5b4-4a9c-8a8f-b037f27caa8f | 18 and over Candidates for the primary trial must have a life expectancy over 6 months. | 0 |
c3257f7b-f5b4-4a9c-8a8f-b037f27caa8f | Sex Candidates for the primary trial must have a life expectancy over 6 months. | 0 |
c3257f7b-f5b4-4a9c-8a8f-b037f27caa8f | Female Candidates for the primary trial must have a life expectancy over 6 months. | 0 |
c3257f7b-f5b4-4a9c-8a8f-b037f27caa8f | Menopausal status Candidates for the primary trial must have a life expectancy over 6 months. | 0 |
c3257f7b-f5b4-4a9c-8a8f-b037f27caa8f | Not specified Candidates for the primary trial must have a life expectancy over 6 months. | 0 |
c3257f7b-f5b4-4a9c-8a8f-b037f27caa8f | Performance status Candidates for the primary trial must have a life expectancy over 6 months. | 0 |
c3257f7b-f5b4-4a9c-8a8f-b037f27caa8f | Not specified Candidates for the primary trial must have a life expectancy over 6 months. | 0 |
c3257f7b-f5b4-4a9c-8a8f-b037f27caa8f | Life expectancy Candidates for the primary trial must have a life expectancy over 6 months. | 0 |
c3257f7b-f5b4-4a9c-8a8f-b037f27caa8f | Not specified Candidates for the primary trial must have a life expectancy over 6 months. | 0 |
c3257f7b-f5b4-4a9c-8a8f-b037f27caa8f | Hematopoietic Candidates for the primary trial must have a life expectancy over 6 months. | 0 |
c3257f7b-f5b4-4a9c-8a8f-b037f27caa8f | Not specified Candidates for the primary trial must have a life expectancy over 6 months. | 0 |
c3257f7b-f5b4-4a9c-8a8f-b037f27caa8f | Hepatic Candidates for the primary trial must have a life expectancy over 6 months. | 0 |
c3257f7b-f5b4-4a9c-8a8f-b037f27caa8f | Not specified Candidates for the primary trial must have a life expectancy over 6 months. | 0 |
c3257f7b-f5b4-4a9c-8a8f-b037f27caa8f | Renal Candidates for the primary trial must have a life expectancy over 6 months. | 0 |
c3257f7b-f5b4-4a9c-8a8f-b037f27caa8f | Not specified Candidates for the primary trial must have a life expectancy over 6 months. | 0 |
c3257f7b-f5b4-4a9c-8a8f-b037f27caa8f | Cardiovascular Candidates for the primary trial must have a life expectancy over 6 months. | 0 |
c3257f7b-f5b4-4a9c-8a8f-b037f27caa8f | No pacemaker Candidates for the primary trial must have a life expectancy over 6 months. | 0 |
c3257f7b-f5b4-4a9c-8a8f-b037f27caa8f | No magnetic aneurysm clips Candidates for the primary trial must have a life expectancy over 6 months. | 0 |
c3257f7b-f5b4-4a9c-8a8f-b037f27caa8f | Other Candidates for the primary trial must have a life expectancy over 6 months. | 0 |
c3257f7b-f5b4-4a9c-8a8f-b037f27caa8f | Not pregnant Candidates for the primary trial must have a life expectancy over 6 months. | 0 |
c3257f7b-f5b4-4a9c-8a8f-b037f27caa8f | No implanted magnetic device Candidates for the primary trial must have a life expectancy over 6 months. | 0 |
c3257f7b-f5b4-4a9c-8a8f-b037f27caa8f | No severe claustrophobia Candidates for the primary trial must have a life expectancy over 6 months. | 0 |
c3257f7b-f5b4-4a9c-8a8f-b037f27caa8f | No other contraindications to MRI Candidates for the primary trial must have a life expectancy over 6 months. | 0 |
c3257f7b-f5b4-4a9c-8a8f-b037f27caa8f | No psychiatric, psychological, or other condition that would preclude informed consent Candidates for the primary trial must have a life expectancy over 6 months. | 0 |
c3257f7b-f5b4-4a9c-8a8f-b037f27caa8f | PRIOR CONCURRENT THERAPY: Candidates for the primary trial must have a life expectancy over 6 months. | 0 |
c3257f7b-f5b4-4a9c-8a8f-b037f27caa8f | Biologic therapy Candidates for the primary trial must have a life expectancy over 6 months. | 0 |
c3257f7b-f5b4-4a9c-8a8f-b037f27caa8f | Not specified Candidates for the primary trial must have a life expectancy over 6 months. | 0 |
c3257f7b-f5b4-4a9c-8a8f-b037f27caa8f | Chemotherapy Candidates for the primary trial must have a life expectancy over 6 months. | 0 |
c3257f7b-f5b4-4a9c-8a8f-b037f27caa8f | At least 6 months since prior anticancer chemotherapy Candidates for the primary trial must have a life expectancy over 6 months. | 0 |
c3257f7b-f5b4-4a9c-8a8f-b037f27caa8f | Endocrine therapy Candidates for the primary trial must have a life expectancy over 6 months. | 0 |
c3257f7b-f5b4-4a9c-8a8f-b037f27caa8f | No concurrent therapeutic hormonal therapy, tamoxifen, or aromatase inhibitors (preventive therapy allowed) Candidates for the primary trial must have a life expectancy over 6 months. | 0 |
c3257f7b-f5b4-4a9c-8a8f-b037f27caa8f | Radiotherapy Candidates for the primary trial must have a life expectancy over 6 months. | 0 |
c3257f7b-f5b4-4a9c-8a8f-b037f27caa8f | Not specified Candidates for the primary trial must have a life expectancy over 6 months. | 0 |
c3257f7b-f5b4-4a9c-8a8f-b037f27caa8f | Surgery Candidates for the primary trial must have a life expectancy over 6 months. | 0 |
c3257f7b-f5b4-4a9c-8a8f-b037f27caa8f | Not specified Candidates for the primary trial must have a life expectancy over 6 months. | 0 |
17a821f8-5e68-4bf7-ac01-3f96ddfc5187 | Age 52-75 years old; Patients eligible for the primary trial must live in the USA. | 1 |
17a821f8-5e68-4bf7-ac01-3f96ddfc5187 | Identification as Latina/Hispanic/Chicana female; Patients eligible for the primary trial must live in the USA. | 1 |
17a821f8-5e68-4bf7-ac01-3f96ddfc5187 | Residence in Pilsen, Little Village, East Side or South Chicago; Patients eligible for the primary trial must live in the USA. | 1 |
17a821f8-5e68-4bf7-ac01-3f96ddfc5187 | No history of health volunteerism; Patients eligible for the primary trial must live in the USA. | 1 |
17a821f8-5e68-4bf7-ac01-3f96ddfc5187 | No history of breast cancer; and Patients eligible for the primary trial must live in the USA. | 1 |
17a821f8-5e68-4bf7-ac01-3f96ddfc5187 | Lack of a mammogram within the last two years Patients eligible for the primary trial must live in the USA. | 1 |
17a821f8-5e68-4bf7-ac01-3f96ddfc5187 | Not meeting all inclusion criteria; Patients eligible for the primary trial must live in the USA. | 1 |
17a821f8-5e68-4bf7-ac01-3f96ddfc5187 | Women will be excluded if they participated in formative focus groups Patients eligible for the primary trial must live in the USA. | 1 |
d76d6c7f-ba39-483c-a89e-152af5ae2878 | primary trial: Placebo secondary trial: Accelerated Intensity Modulated Radiation Therapy (AIMRT) Patients in group 1 of the secondary trial and the primary trial do not receive the same dosage of AIMRT. | 1 |
d76d6c7f-ba39-483c-a89e-152af5ae2878 | primary trial: Placebo secondary trial: All patients shall receive a total of 40.5 Gy to the entire breast in 2.7 Gy/fraction x 15 fractions, Monday to Friday for 3 weeks delivered prone in uniform daily doses through IMRT tangent fields. A concurrent boost to the original tumor bed of 0.50 Gy will be delivered. Patients in group 1 of the secondary trial and the primary trial do not receive the same dosage of AIMRT. | 1 |
d76d6c7f-ba39-483c-a89e-152af5ae2878 | primary trial: Placebo secondary trial: Accelerated intensity modulated radiation therapy (AIMRT) Patients in group 1 of the secondary trial and the primary trial do not receive the same dosage of AIMRT. | 1 |
d76d6c7f-ba39-483c-a89e-152af5ae2878 | primary trial: Subjects will be randomly selected to receive saline (placebo), administered to the breast area to cover the intercostal nerves supplying the breast tissue during surgery. secondary trial: Accelerated Intensity Modulated Radiation Therapy (AIMRT) Patients in group 1 of the secondary trial and the primary trial do not receive the same dosage of AIMRT. | 1 |
d76d6c7f-ba39-483c-a89e-152af5ae2878 | primary trial: Subjects will be randomly selected to receive saline (placebo), administered to the breast area to cover the intercostal nerves supplying the breast tissue during surgery. secondary trial: All patients shall receive a total of 40.5 Gy to the entire breast in 2.7 Gy/fraction x 15 fractions, Monday to Friday for 3 weeks delivered prone in uniform daily doses through IMRT tangent fields. A concurrent boost to the original tumor bed of 0.50 Gy will be delivered. Patients in group 1 of the secondary trial and the primary trial do not receive the same dosage of AIMRT. | 1 |
d76d6c7f-ba39-483c-a89e-152af5ae2878 | primary trial: Subjects will be randomly selected to receive saline (placebo), administered to the breast area to cover the intercostal nerves supplying the breast tissue during surgery. secondary trial: Accelerated intensity modulated radiation therapy (AIMRT) Patients in group 1 of the secondary trial and the primary trial do not receive the same dosage of AIMRT. | 1 |
d76d6c7f-ba39-483c-a89e-152af5ae2878 | primary trial: Saline: If randomized to this arm, subjects will receive an intraoperative injection of saline. (2.5 mg/ml) secondary trial: Accelerated Intensity Modulated Radiation Therapy (AIMRT) Patients in group 1 of the secondary trial and the primary trial do not receive the same dosage of AIMRT. | 1 |
d76d6c7f-ba39-483c-a89e-152af5ae2878 | primary trial: Saline: If randomized to this arm, subjects will receive an intraoperative injection of saline. (2.5 mg/ml) secondary trial: All patients shall receive a total of 40.5 Gy to the entire breast in 2.7 Gy/fraction x 15 fractions, Monday to Friday for 3 weeks delivered prone in uniform daily doses through IMRT tangent fields. A concurrent boost to the original tumor bed of 0.50 Gy will be delivered. Patients in group 1 of the secondary trial and the primary trial do not receive the same dosage of AIMRT. | 1 |
d76d6c7f-ba39-483c-a89e-152af5ae2878 | primary trial: Saline: If randomized to this arm, subjects will receive an intraoperative injection of saline. (2.5 mg/ml) secondary trial: Accelerated intensity modulated radiation therapy (AIMRT) Patients in group 1 of the secondary trial and the primary trial do not receive the same dosage of AIMRT. | 1 |
d76d6c7f-ba39-483c-a89e-152af5ae2878 | primary trial: 0.25 % Bupivacaine w/ Epinephrine & 4mg Dexamethasone secondary trial: Accelerated Intensity Modulated Radiation Therapy (AIMRT) Patients in group 1 of the secondary trial and the primary trial do not receive the same dosage of AIMRT. | 1 |
d76d6c7f-ba39-483c-a89e-152af5ae2878 | primary trial: 0.25 % Bupivacaine w/ Epinephrine & 4mg Dexamethasone secondary trial: All patients shall receive a total of 40.5 Gy to the entire breast in 2.7 Gy/fraction x 15 fractions, Monday to Friday for 3 weeks delivered prone in uniform daily doses through IMRT tangent fields. A concurrent boost to the original tumor bed of 0.50 Gy will be delivered. Patients in group 1 of the secondary trial and the primary trial do not receive the same dosage of AIMRT. | 1 |
d76d6c7f-ba39-483c-a89e-152af5ae2878 | primary trial: 0.25 % Bupivacaine w/ Epinephrine & 4mg Dexamethasone secondary trial: Accelerated intensity modulated radiation therapy (AIMRT) Patients in group 1 of the secondary trial and the primary trial do not receive the same dosage of AIMRT. | 1 |
d76d6c7f-ba39-483c-a89e-152af5ae2878 | primary trial: Subjects will be randomly selected to receive selective block with a local anesthetic solution containing 0.25 % bupivacaine (2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasone. The injection will be performed in certain locations of the breast area to cover the intercostal nerves supplying the breast tissue. secondary trial: Accelerated Intensity Modulated Radiation Therapy (AIMRT) Patients in group 1 of the secondary trial and the primary trial do not receive the same dosage of AIMRT. | 1 |
d76d6c7f-ba39-483c-a89e-152af5ae2878 | primary trial: Subjects will be randomly selected to receive selective block with a local anesthetic solution containing 0.25 % bupivacaine (2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasone. The injection will be performed in certain locations of the breast area to cover the intercostal nerves supplying the breast tissue. secondary trial: All patients shall receive a total of 40.5 Gy to the entire breast in 2.7 Gy/fraction x 15 fractions, Monday to Friday for 3 weeks delivered prone in uniform daily doses through IMRT tangent fields. A concurrent boost to the original tumor bed of 0.50 Gy will be delivered. Patients in group 1 of the secondary trial and the primary trial do not receive the same dosage of AIMRT. | 1 |
d76d6c7f-ba39-483c-a89e-152af5ae2878 | primary trial: Subjects will be randomly selected to receive selective block with a local anesthetic solution containing 0.25 % bupivacaine (2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasone. The injection will be performed in certain locations of the breast area to cover the intercostal nerves supplying the breast tissue. secondary trial: Accelerated intensity modulated radiation therapy (AIMRT) Patients in group 1 of the secondary trial and the primary trial do not receive the same dosage of AIMRT. | 1 |
d76d6c7f-ba39-483c-a89e-152af5ae2878 | primary trial: Subjects will be randomly selected to receive the local anesthetic solution containing 0.25 % bupivacaine (2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasoneadministered to the breast area to cover the intercostal nerves supplying the breast tissue during surgery. secondary trial: Accelerated Intensity Modulated Radiation Therapy (AIMRT) Patients in group 1 of the secondary trial and the primary trial do not receive the same dosage of AIMRT. | 1 |
d76d6c7f-ba39-483c-a89e-152af5ae2878 | primary trial: Subjects will be randomly selected to receive the local anesthetic solution containing 0.25 % bupivacaine (2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasoneadministered to the breast area to cover the intercostal nerves supplying the breast tissue during surgery. secondary trial: All patients shall receive a total of 40.5 Gy to the entire breast in 2.7 Gy/fraction x 15 fractions, Monday to Friday for 3 weeks delivered prone in uniform daily doses through IMRT tangent fields. A concurrent boost to the original tumor bed of 0.50 Gy will be delivered. Patients in group 1 of the secondary trial and the primary trial do not receive the same dosage of AIMRT. | 1 |
d76d6c7f-ba39-483c-a89e-152af5ae2878 | primary trial: Subjects will be randomly selected to receive the local anesthetic solution containing 0.25 % bupivacaine (2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasoneadministered to the breast area to cover the intercostal nerves supplying the breast tissue during surgery. secondary trial: Accelerated intensity modulated radiation therapy (AIMRT) Patients in group 1 of the secondary trial and the primary trial do not receive the same dosage of AIMRT. | 1 |
d76d6c7f-ba39-483c-a89e-152af5ae2878 | primary trial: 0.25 % bupivacaine (2.5 mg/ml) w/ 1:100,000 epinephrine & 4 mg dexamethasone: If randomized to this arm, subjects will receive a selective block with a local anesthetic solution containing 0.25 % bupivacaine. secondary trial: Accelerated Intensity Modulated Radiation Therapy (AIMRT) Patients in group 1 of the secondary trial and the primary trial do not receive the same dosage of AIMRT. | 1 |
d76d6c7f-ba39-483c-a89e-152af5ae2878 | primary trial: 0.25 % bupivacaine (2.5 mg/ml) w/ 1:100,000 epinephrine & 4 mg dexamethasone: If randomized to this arm, subjects will receive a selective block with a local anesthetic solution containing 0.25 % bupivacaine. secondary trial: All patients shall receive a total of 40.5 Gy to the entire breast in 2.7 Gy/fraction x 15 fractions, Monday to Friday for 3 weeks delivered prone in uniform daily doses through IMRT tangent fields. A concurrent boost to the original tumor bed of 0.50 Gy will be delivered. Patients in group 1 of the secondary trial and the primary trial do not receive the same dosage of AIMRT. | 1 |
d76d6c7f-ba39-483c-a89e-152af5ae2878 | primary trial: 0.25 % bupivacaine (2.5 mg/ml) w/ 1:100,000 epinephrine & 4 mg dexamethasone: If randomized to this arm, subjects will receive a selective block with a local anesthetic solution containing 0.25 % bupivacaine. secondary trial: Accelerated intensity modulated radiation therapy (AIMRT) Patients in group 1 of the secondary trial and the primary trial do not receive the same dosage of AIMRT. | 1 |
d76d6c7f-ba39-483c-a89e-152af5ae2878 | primary trial: (2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasone intraoperatively. secondary trial: Accelerated Intensity Modulated Radiation Therapy (AIMRT) Patients in group 1 of the secondary trial and the primary trial do not receive the same dosage of AIMRT. | 1 |
d76d6c7f-ba39-483c-a89e-152af5ae2878 | primary trial: (2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasone intraoperatively. secondary trial: All patients shall receive a total of 40.5 Gy to the entire breast in 2.7 Gy/fraction x 15 fractions, Monday to Friday for 3 weeks delivered prone in uniform daily doses through IMRT tangent fields. A concurrent boost to the original tumor bed of 0.50 Gy will be delivered. Patients in group 1 of the secondary trial and the primary trial do not receive the same dosage of AIMRT. | 1 |
d76d6c7f-ba39-483c-a89e-152af5ae2878 | primary trial: (2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasone intraoperatively. secondary trial: Accelerated intensity modulated radiation therapy (AIMRT) Patients in group 1 of the secondary trial and the primary trial do not receive the same dosage of AIMRT. | 1 |
65f3e755-3e23-4e84-a218-87922759094d | primary trial: Post-menopausal Women Using Adjuvant Letrozole secondary trial: Neratinib 40 mg the primary trial administers letrozole for 28 days, whereas the secondary trial administers is intervention over 4 cycles of 21 days. | 0 |
65f3e755-3e23-4e84-a218-87922759094d | primary trial: Post-menopausal Women Using Adjuvant Letrozole secondary trial: Neratinb 40 mg qd the primary trial administers letrozole for 28 days, whereas the secondary trial administers is intervention over 4 cycles of 21 days. | 0 |
65f3e755-3e23-4e84-a218-87922759094d | primary trial: Post-menopausal Women Using Adjuvant Letrozole secondary trial: Neratinib 80 mg the primary trial administers letrozole for 28 days, whereas the secondary trial administers is intervention over 4 cycles of 21 days. | 0 |
65f3e755-3e23-4e84-a218-87922759094d | primary trial: Post-menopausal Women Using Adjuvant Letrozole secondary trial: Neratinib 80 mg qd the primary trial administers letrozole for 28 days, whereas the secondary trial administers is intervention over 4 cycles of 21 days. | 0 |
65f3e755-3e23-4e84-a218-87922759094d | primary trial: Part A Routine Care Letrozole; Part B Double Dose Letrozole in overweight/obese participants secondary trial: Neratinib 40 mg the primary trial administers letrozole for 28 days, whereas the secondary trial administers is intervention over 4 cycles of 21 days. | 0 |
65f3e755-3e23-4e84-a218-87922759094d | primary trial: Part A Routine Care Letrozole; Part B Double Dose Letrozole in overweight/obese participants secondary trial: Neratinb 40 mg qd the primary trial administers letrozole for 28 days, whereas the secondary trial administers is intervention over 4 cycles of 21 days. | 0 |
65f3e755-3e23-4e84-a218-87922759094d | primary trial: Part A Routine Care Letrozole; Part B Double Dose Letrozole in overweight/obese participants secondary trial: Neratinib 80 mg the primary trial administers letrozole for 28 days, whereas the secondary trial administers is intervention over 4 cycles of 21 days. | 0 |
65f3e755-3e23-4e84-a218-87922759094d | primary trial: Part A Routine Care Letrozole; Part B Double Dose Letrozole in overweight/obese participants secondary trial: Neratinib 80 mg qd the primary trial administers letrozole for 28 days, whereas the secondary trial administers is intervention over 4 cycles of 21 days. | 0 |
65f3e755-3e23-4e84-a218-87922759094d | primary trial: Letrozole: Part A Monitor standard of care letrozole use for 28 days; measure blood levels of estrogens and vitamin D at start and end of period. Part B In overweight/obese participants who completed Part A, provide a double dose of letrozole and monitor use for 28 days; measure blood levels of estrogens and vitamin D at start and end of period. secondary trial: Neratinib 40 mg the primary trial administers letrozole for 28 days, whereas the secondary trial administers is intervention over 4 cycles of 21 days. | 0 |
65f3e755-3e23-4e84-a218-87922759094d | primary trial: Letrozole: Part A Monitor standard of care letrozole use for 28 days; measure blood levels of estrogens and vitamin D at start and end of period. Part B In overweight/obese participants who completed Part A, provide a double dose of letrozole and monitor use for 28 days; measure blood levels of estrogens and vitamin D at start and end of period. secondary trial: Neratinb 40 mg qd the primary trial administers letrozole for 28 days, whereas the secondary trial administers is intervention over 4 cycles of 21 days. | 0 |
65f3e755-3e23-4e84-a218-87922759094d | primary trial: Letrozole: Part A Monitor standard of care letrozole use for 28 days; measure blood levels of estrogens and vitamin D at start and end of period. Part B In overweight/obese participants who completed Part A, provide a double dose of letrozole and monitor use for 28 days; measure blood levels of estrogens and vitamin D at start and end of period. secondary trial: Neratinib 80 mg the primary trial administers letrozole for 28 days, whereas the secondary trial administers is intervention over 4 cycles of 21 days. | 0 |
65f3e755-3e23-4e84-a218-87922759094d | primary trial: Letrozole: Part A Monitor standard of care letrozole use for 28 days; measure blood levels of estrogens and vitamin D at start and end of period. Part B In overweight/obese participants who completed Part A, provide a double dose of letrozole and monitor use for 28 days; measure blood levels of estrogens and vitamin D at start and end of period. secondary trial: Neratinib 80 mg qd the primary trial administers letrozole for 28 days, whereas the secondary trial administers is intervention over 4 cycles of 21 days. | 0 |
d3590771-806b-4754-a455-38113bfedfca | The following criteria are to be checked at the time of study entry. The patients may only be included in the study if ALL of the following statements are FULLFILLED: Candidates for the primary trial must have adequate colon and liver function, and must not be currently receiving amiodarone or have received amiodarone in the last 28 day. Renal function is not relevant for inclusion. | 0 |
d3590771-806b-4754-a455-38113bfedfca | The patient (male or female) is at least 18 years old at the time of signature of the informed consent form. Candidates for the primary trial must have adequate colon and liver function, and must not be currently receiving amiodarone or have received amiodarone in the last 28 day. Renal function is not relevant for inclusion. | 0 |
d3590771-806b-4754-a455-38113bfedfca | Written informed consent has been obtained from the patient prior to the performance of any protocol-specific procedure. Candidates for the primary trial must have adequate colon and liver function, and must not be currently receiving amiodarone or have received amiodarone in the last 28 day. Renal function is not relevant for inclusion. | 0 |
d3590771-806b-4754-a455-38113bfedfca | The patient is diagnosed with confirmed invasive breast cancer with stage IV disease. Candidates for the primary trial must have adequate colon and liver function, and must not be currently receiving amiodarone or have received amiodarone in the last 28 day. Renal function is not relevant for inclusion. | 0 |
d3590771-806b-4754-a455-38113bfedfca | Note: If the metastatic disease is restricted to a solitary lesion, its neoplastic nature should be confirmed by cytology or histology. Candidates for the primary trial must have adequate colon and liver function, and must not be currently receiving amiodarone or have received amiodarone in the last 28 day. Renal function is not relevant for inclusion. | 0 |
d3590771-806b-4754-a455-38113bfedfca | The patient has documented disease progression or relapse following at least one prior standard therapy with trastuzumab (alone or in combination with chemotherapy). Candidates for the primary trial must have adequate colon and liver function, and must not be currently receiving amiodarone or have received amiodarone in the last 28 day. Renal function is not relevant for inclusion. | 0 |
d3590771-806b-4754-a455-38113bfedfca | Patients with prior lapatinib use are eligible. Furthermore, Candidates for the primary trial must have adequate colon and liver function, and must not be currently receiving amiodarone or have received amiodarone in the last 28 day. Renal function is not relevant for inclusion. | 0 |
d3590771-806b-4754-a455-38113bfedfca | The administration of the chemotherapeutic agent(s) should have been stopped for at least 28 days by the time of the first ASCI administration. Candidates for the primary trial must have adequate colon and liver function, and must not be currently receiving amiodarone or have received amiodarone in the last 28 day. Renal function is not relevant for inclusion. | 0 |
d3590771-806b-4754-a455-38113bfedfca | The administration of trastuzumab alone could be maintained after chemotherapy, but the last dose of trastuzumab should not have been given less than three weeks before the first ASCI administration. Candidates for the primary trial must have adequate colon and liver function, and must not be currently receiving amiodarone or have received amiodarone in the last 28 day. Renal function is not relevant for inclusion. | 0 |
d3590771-806b-4754-a455-38113bfedfca | The patient will not be given trastuzumab during the trial. Candidates for the primary trial must have adequate colon and liver function, and must not be currently receiving amiodarone or have received amiodarone in the last 28 day. Renal function is not relevant for inclusion. | 0 |