*Lab registration is required for site approval. Please check your site's status.*

-Patients must have histologically confirmed non-metastatic primary triple negative invasive adenocarcinoma of the breast that is one of the following at surgery:
--axillary node-positive (any tumour size)
--axillary node-negative with primary tumour greater than 2cm for patients who received adjuvant chemotherapy
--showing evidence of non pCR for patients who received neoadjuvant chemotherapy
-Patients must have documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function)
-Patients must have completed adequate breast and axilla surgery
-Patients must have completed at least 6 cycles neoadjuvant or adjuvant chemotherapy containing anthracyclines, taxanes or the combination of both.
-ECOG performance status must be 0-1
-Patients must not have evidence of metastatic breast cancer.
-Patients must not have any previous treatment with a PARP inhibitor, including olaparib and/or known hypersensitivity to any of the study drugs.
-Patients must not have received systemic chemotherapy within 3 weeks prior to start of study treatment.
-Patients must not have received adjuvant radiotherapy within 2 weeks prior to start of study treatment
-Patients must not have had previous allogeneic bone marrow transplant.
-Patients must not have had whole blood transfusions in the last 120 days prior to entry to the study which may interfere with gBRCA testing

***ONLY OPEN TO SJMH Ann Arbor, Canton, Chelsea and Brighton***

Stage IIA closed to accrual effective 8/28/17.

-Premenopausal and postmenopausal women or men with Stage II or Stage III early invasive breast cancer.
-Disease must be hormone receptor positive, HER2-
-Must have undergone breast surgery for the current malignancy
-ECOG PS 0-1
-Patients may or may not have received neo/adjuvant tx, but must be after last dose of chemo and/or biologic tx
-Patients may or may not have received breast/ axilla/ post-mastectomy chest wall RT, but must be after last dose of RT
-Patient must have sufficient resolution of side effects
-Patients must be either initiating or have already started adjuvant hormonal tx. Randomization must take place within 12 mo of diagnosis and 6 mo of initiating endocrine therapy. Patients who received neoadjuvant endocrine therapy are eligible as long as they are enrolled within 12 mo of diagnosis and after completing no more than 6 mo of adjuvant endocrine therapy.
-Must NOT have prior tx with a CDK inhibitor

**This study is closed to accrual effective 09/14/12**

**Follow ECOG specimen submission requirements.**

***01/23/12 CALGB posted a broadcast regarding the national daunorubicin shortage.  Access the link on the C10403 abstract page on the SWOG website***

DISEASE CHARACTERISTICS:

Newly diagnosed acute lymphoblastic leukemia (ALL)

B-precursor or T-precursor ALL

No Burkitt type leukemia (FAB L3; SIg positive; t(8;14) or variant)

No known Ph+ ALL at time of diagnosis

Enrollment on CALGB-C10001 (or its successor trial) for CALGB patients with Philadelphia-positive ALL take priority over enrollment on this protocol

Patients enrolled on this study but are later found to meet the following criteria for Ph+ ALL eligibility criteria for protocol CALGB-C10001 (or its successor trial) are removed from this study and enrolled on CALGB-C10001 (or its successor study):



BCR-ABL fusion transcript determined by FISH or RT-PCR

t(9;22)(q34;q11) or variant determined by cytogenetics

All CALGB patients are required to participate in CALGB-8461

All SWOG patients are required to participate in SWOG-9007

PATIENT CHARACTERISTICS:



ECOG performance status 0-2

No Down syndrome

PRIOR CONCURRENT THERAPY:



No prior therapy for acute leukemia except emergency therapy (i.e., corticosteroids or hydroxyurea) for blast cell crisis, superior vena cava syndrome, or renal failure due to leukemic infiltration of the kidneys

Single-dose intrathecal cytarabine is allowed prior to registration for patient convenience provided systemic chemotherapy begins within 72 hours of intrathecal therapy

Prior steroid therapy allowed

-Histologically confirmed adenocarcinoma of the colon
-Gross inferior (caudal) margin of the primary tumor must lie above the peritoneal reflection
-Tumors must have been completely resected.
-Disease must be node positive.
-Patients with resected stage IV disease are not eligible.
-No evidence of residual involved LN or metastatic diease at the time of registration.
-Patients with synchronous colon cancers are eligible.
-ECOG performance status must be 0-2

This study is open to SJMH (AA, Brighton, Canton & Chelsea) only. Patient's must be treated within 3 calendar days of randomization

-Histological or cytological evidence of metastatic or surgically unresectable transitional

cell carcinoma (TCC) of the urothelium involving the renal pelvis, ureter, bladder or

urethra. Minor histologic variants (< 50% overall) are acceptable.
-Patients must have measurable disease.
-Prior systemic chemotherapy for metastatic or surgically unresectable UC is not allowed
--Prior intravesical therapy is permitted if completed at least 4 weeks prior to the initiation of study treatment.
--Prior neoadjuvant chemotherapy, radiation or prior adjuvant platinum-based chemotherapy following radical cystectomy with recurrence =12 months from completion of therapy is permitted.

-ECOG PS must be 0-1
-Patient must not have disease that is suitable for local, curative therapy
-Must not have active brain or leptomeningeal mets.
-Patients must not require immunosuppressive doses of systemic corticosteroids
-All toxicities attributed to prior treatment, other than alopecia and fatigue, must have resolved to grade 1 or baseline. Patients with peripheral neuropathy after platinum-based therapy are eligible.

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

**Submission of the treating investigators CV is required to order Bendamustine**

-Histologically confirmed follicular non-Hodgkin lymphoma, WHO classification grade 1, 2, or 3a (greater than 15 centroblasts per high-power field with centrocytes present)
-Bone marrow biopsies as the sole means of diagnosis are not acceptable, but they may be submitted in conjunction with nodal biopsies. Fine-needle aspirates are not acceptable.
-Patients must have poor-risk disease defined by one of the following 2 criteria:
--greater than or equal to 3 risk factors by the Follicular Lymphoma International Prognostic Index
--2 risk factors by FLIPI and at least one bulky mass or lymph node greater than 6cm in size
-Measurable disease must be present either on physical examination or imaging studies. Any tumor mass > 1 cm is acceptable
-No known CNS involvement by lymphoma
-ECOG performance status 0-2
-No prior cytotoxic chemotherapy, radiotherapy, immunotherapy, or radioimmunotherapy
-No corticosteroids are permitted, except for maintenance therapy for a nonmalignant disease or to prevent treatment-related ofatumumab reactions

This study is open to SJMH (Ann Arbor, Brighton, Canton & Chelsea only)

Fax Inclusion Checklist to PPD for review prior to induction entry in IVRS. PPD fax # is on enrollment forms, last page.

-Histologically confirmed Follicular Lymphoma (Grade 1, 2, 3a or 3b), transformed FL, Marginal Zone Lymphoma, or Mantle Cell Lymphoma
-Must have been previously treated with at least one prior treatment for lymphoma including RT, chemotherapy, immunotherapy, chemoimmunotherapy, or novel agent.
-Must have documented relapsed, refractory or progressive disease after last treatment.
-Patients must have bi-dimensionally measurable disease with at least one lesion greater than 1.5cm in the transverse diameter.
-Must be in need of treatment for relapsed or refractory disease.
-ECOG Performance status must be 0-2.
-Must not have presence or history of CNS involvement by lymphoma.
-Must not have any medical condition other than lymphoma that requires chronic steroid use.
-Patients must not have had systemic therapy or major surgery within 28d prior to D1 (radioimmunotherapy within 3mo).
-Must not have had prior use of Lenalidomide.

**This study is open to SJMH (AA, Brighton, Canton & Chelsea) only. Safety Run is complete. T2N0M0 patients can no longer be screened (16FEB2024)

AZ’s recommendation is to randomize subject while subject is on site

*Check eligible studies list in document library.
-All patients (pediatric and adults) screened for selected NCORP trials supported by the Division of

Cancer Prevention (DCP). These trials include symptom and toxicity management, prevention,

screening, post-treatment surveillance and comparative effectiveness. Cancer care delivery clinical

trials will be included if the primary aim focuses on a patient intervention. A screened patient will be

defined as one meeting the following minimum eligibility criteria per the protocol being screened for:-

--Cancer diagnosis including stage and histology or pre-malignancy
--Age range specified in the protocol for which the patient is being screened
--Indication for the study intervention (e.g., symptom, toxicity)

Pre-Registration Eligibility:

-Histologically confirmed untreated mantle cell lymphoma (MCL), with documented cyclin D1 by immunohistochemical stains and/or t(11;14) by cytogenetics or FISH
-Patients must have measurable disease
-Patient must have no CNS involvement
-ECOG performance status 0-2
-No prior therapy for MCL, except < 2 weeks of steroid therapy for symptom control or local RT for symptom control if there is measurable disease outside the RT portal

Registration Eligibility:
-ECOG PS between 0-2
-CR, PR, or SD after step 1