1.0) Path (+) breast ca w/clinical evidence of Measurable mets (bone-only dz are eligible)
2.0) 1 prior tx for met dz or failure w/in 6mo's of adjuvent tx- at least one tx with anthracycline or taxane
3.0) RT ok if = 25% of bone marrow

1.0) Recurrent or advanced NSCLC. Recurrent NSCLC must be histo. confirmed if > 1 year since initial diagnosis.
2.0) Pt. must have bidimensionally measurable lesion. (Exception for pts. who achieved a CR from prior therapy.)
3.0) Pt. must have received 4-8 cycles of induction chemo.
4.0) Pt. may not have recieved more than 2 prior regimens.
5.0) Pts. must have completed prior tx within 3-8 wks of enrollment and must begin tx in this study within 8 wks of last dose of prior chemo.
6.0) Pt. may have recieved prior taxol if given on a > 3wk schedule.

1.0) Pt. must have achieved a CR or PR after 1 prior chemo and/or RT Tx.
2.0) Pt. with limited stage SCLC must be randomized 3-12 wks from last dose of chemo, and when relevant > 2wks from RT.
3.0) Pt. with extensive stage SCLC must be randomized 3-6 wks from last dose of chemo.
4.0) Life expectancy >/= 12 weeks.

***SJMH will NOT be participating in this study***

*Credentialing required. Please check your site's credentialing status.*
CURRENT SITES CREDENTIALED:
Genesys, Oakland, St. Alphonsus, St. John

*Check for eligibility to DCP-001*
-Patients must be female.
-Pathologically confirmed diagnosis of breast cancer, clinical stage I-II (T1-3 N0 M0, T0-2 N1 M0).
-Diagnosis must be by needle biopsy; patients diagnosed by surgical excision are excluded
-Patients must have ER and PR negative breast cancer
-No patients with previous ipsilateral invasive breast cancer or DCIS
-No patients with bilateral breast cancer
-No patients with known deleterious mutations in breast cancer (BRCA) genes
-No current history of receiving hormonal therapy, tamoxifen, and or aromatase inhibitors for therapeutic measures
-No history of chemotherapy for cancer within 6 months prior to registration
-No patients scheduled to receive partial breast irradiation following breast conserving surgery
-Patients must be eligible for breast conserving therapy
-Patients must be suitable to undergo MRI
-No prior MRI of study breast within the 12 months prior to registration
-No history of breast biopsy (including FNA) of the study breast within 6 months prior to the MRI

-Neoadjuvant chemotherapy patients are allowed

-Pathologic confirmation of invasive breast cancer diagnosed by core needle biopsy
-Clinical T2-T4c, any N, M0 invasive breast cancer with the goal being surgery to complete excision of the tumor in the breast and the lymph node.
-The extent of disease is a solitary lesion where the lesion is palpable, can be measured bidimensionally, and largest diameter is at least 2cm.
-Patients with contralateral ductal carcinoma in situ and/or invasive breast cancer are NOT eligible.

-Patients with multi-focal breast cancer (defined as more than one lesion of invasive breast cancer in the same breast separated from the dominant breast lesion by less than 5 cm of radiologically normal breast tissue) are eligible.

-Disease must be ER positive
-Disease must be HER2 negative
-ECOG PS 0-2
-Patients must be postmenopausal
-No prior treatment for this cancer including surgery, radiation therapy, chemotherapy, biotherapy, hormonal therapy or investigational agent prior to study entry.

**Effective 09/01/2020,  Step 2 (Confirmation of Evaluability) registration is temporarily unavailable for new registrations**

*Credentials required. Please check your site's credentialing status.*
CURRENT SITES CREDENTIALED:
SJMH-(A2, Canton only), Livonia, Genesys Hurley, St. Alphonsus, Oakwood, St. John Hospital, Oakland, Macomb, St. Mays Saginaw, Holy Cross, Sparrow

*Patients may simultaneously enroll to BWEL A011401, if eligible.

Pre-Registration Eligibility Criteria:
-Clinical stage T1-3 N1 M0 breast cancer at diagnosis (prior to the start of neoadjuvant chemotherapy)
-No inflammatory breast cancer
-All patients must have had an axillary ultrasound with fine needle aspiration (FNA) or core needle biopsy of axillary lymph nodes documenting axillary metastasis at the time of diagnosis, prior to neoadjuvant chemotherapy.
-Patients must have completed at least 6 cycles of neoadjuvant chemotherapy consisting of an anthracycline and/or taxane-based regimen without evidence of disease progression in the breast or the lymph nodes.
-Patients must have completed all planned chemotherapy prior to surgery. Sandwich chemotherapy is not allowed (i.e. chemotherapy planned to be given after surgery).
-Patients with HER-2 positive tumors must have received neoadjuvant trastuzumab or other approved anti-HER-2 therapy
-All patients must have a clinically negative axilla (no palpable lymph nodes or bulky adenopathy) on physical examination documented at the completion of neoadjuvant chemotherapy.
-No more than 8 weeks of neoadjuvant endocrine therapy prior to the start of neoadjuvant chemo.
-No neoadjuvant radiation therapy.
-No sentinel lymph node (SLN) surgery/excisional biopsy for pathological confirmation of axillary status prior to or during neoadjuvant chemotherapy.
-No prior ipsilateral axillary surgery, such as excisional biopsy of lymph node(s) or treatment of hidradenitis.
-ECOG PS 0-1

Post-Operative Eligibility Criteria: [For cases where ALND has not been performed and one of the following is true:  --intra-operative evaluation of sentinel lymph node could not be/was not performed and final pathology identified a positive SLN with metastasis greater than 0.2 mm OR --sentinel lymph node on intra-operative evaluation considered negative was found to be positive on final pathology (with metastasis greater than 0.2 mm).]
-Breast surgery (lumpectomy or mastectomy) and sentinel lymph node surgery must be completed within 56 days of the completion of neoadjuvant chemotherapy.
-Among the minimum of 2 and the maximum of 6 sentinel nodes identified and excised by the surgeon, no more than 8 lymph nodes (sentinel and non-sentinel) were found by the pathologists to have been actually excised.
-For those patients who also undergo contralateral breast surgery, if invasive disease is found in the contralateral breast, the patient is not eligible for registration /randomization. 

Pre-registration Eligibility:
-Women who agree to undergo a standard of care core biopsy of recurrent or metastatic breast cancer to confirm that is ER+ and HER2 negative
-Patient must have been previously treated with an aromatase inhibitor either in the adjuvant or metastatic setting, and have primary or secondary endocrine resistant disease defined as follows--

Primary clinical resistance:
--Recurrence within the first 2 years of adjuvant endocrine therapy while on endocrine therapy OR 
--Progression within first 6 months of initiating first-line endocrine therapy for the treatment of metastatic breast cancer (while on endocrine therapy);

Secondary clinical resistance:
--Recurrence during years 2-5 of adjuvant endocrine therapy (or within 12 months of completing adjuvant endocrine therapy OR
--Progression occurring 6 or more months after initiating endocrine therapy for metastatic disease while on endocrine therapy
-Must have history of measurable disease 
-No history of visceral crisis, lymphangitic spread or known brain metastases.
-Women must be postmenopausal
-No more than two prior chemotherapy regimens in the metastatic setting.
-Prior treatment with an aromatase inhibitor (either anastrozole, letrozole or exemestane), either in the adjuvant or metastatic setting is required.
-Unlimited prior endocrine regimens in the metastatic setting, which may have included an everolimus containing regimen.
-Prior tamoxifen treatment is allowed in the adjuvant setting, but patients must not have experienced relapse within 1 year of stopping tamoxifen.
-No prior treatment with tamoxifen in the metastatic setting.
-ECOG PS 0-2  

Registration Eligibility:
-Must have measurable disease or bone only disease 
-No visceral crisis, lymphangitic spread or known brain metastases. 
-Histologic confirmation from pre-registration that locally advanced or metastatic breast cancer is estrogen receptor positive and HER2 negative.
-None of the following therapies are allowed within 2 weeks prior to registration: chemotherapy, immunotherapy, biologic therapy, hormonal therapy, monoclonal antibodies, radiation therapy, anti-HER2 or other targeted therapy. 

***Patients must not have metastatic breast cancer***

*Effective 07/06/17 Sub-study HO1 is Closed to Accrual.

*Effective 02/01/2021, Step 1 is Closed to Accrual.  

*Effective 03/25/2021, Step 2 patient randomization is Closed to Accrual. 
*Check for eligibility to DCP-001*

-Subjects must have histologically confirmed invasive breast cancer with diagnosis within the past 12mo.
--Neoadjuvant subjects should have no evidence of clinical T4 disease prior to chemo and surgery.
--Bilateral disease is allowed provided diagnoses are synchronous
-Must be HER-2 negative
-Eligible TNM stages include:
--ER and PR negative for T2 or T3 N0, T0-3N1-3
--ER and/or PR positive for T0-3N1-3 or T3N0
-All adjuvant or neoadjuvant chemo and surgery must be completed at least 21 days prior to registration
-Surgical margins must be clear
-All subjects must have sentinel lymph node biopsy and/or axillary lymph node dissection
-All women who undergo breast conserving therapy must receive concomitant radiotherapy. RT can be administered prior to or during protocol treatment.
-Patients with hormone receptor positive disease must receive at least 5 years of adjuvant hormonal therapy initiated prior to or during protocol treatment.
-ECOG PS must be 0-1.
-No history of comorbid conditions that preclude moderate physical activity.
-Must not have had bariatric surgery or plan to in the next 2 years.
-BMI must be greater than or equal to 27 kg/m2 within 56 days prior to registration.
-Must have self-reported ability to walk at least 2 blocks.
-Must not be participating in another weight loss, physical activity or dietary intervention clinical trial. Subjects may co-enroll in pharmacologic therapy trials.
-Must be able to read and comprehend English.

**As of 2/15/17, per on-study guidelines, patients should not be planning to undergo a major surgical procedure (e.g. hysterectomy) within 3 months after study registration.  (Breast reconstruction is allowed during study participation)**