*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

CREDENTIALING REQUIRED. Please check your site's credentialing status.

CURRENT SITES CREDENTIALED:

Eligibility Criteria:

3.1.1 Patients must be women with newly diagnosed histologically proven invasive carcinoma of the breast with no evidence of metastases, staged as per site standard of care.

3.1.2 Patients must have been treated by BCS or mastectomy with clear margins of excision*.

* Patients treated by BCS with focally positive margins for invasive breast cancer or DCIS (involving < 3 high power fields) are eligible if additional surgery is not possible, e.g. posterior margin positive and deep resection margin abuts the chest wall or anterior margin positive and superficial resection margin abuts the skin. Boost radiotherapy must be administered for positive margins as described above.

Post-mastectomy positive margins for invasive breast cancer and/or DCIS is not allowed.

 Multifocal disease (i.e. the presence of two or more foci of breast cancer within the same breast quadrant) and multicentric disease (i.e. the presence of two or more foci of breast cancer in different quadrants of the same breast) are allowed.

3.1.3 Patients with T3N0 disease are eligible.

3.1.4 Patients with disease limited to nodal micrometastases are eligible.

3.1.5 Patients with nodal macrometastases (> 2 mm) treated by axillary dissection must have 1-3 positive axillary nodes (macrometastases, > 2 mm)*.

3.1.6 Patients with nodal macrometastases (> 2 mm) treated by SLNB alone must have only 1-2 positive axillary nodes (macrometastases, > 2 mm)*.  

* Note patients with additional nodal micrometastases (> 0.2-2mm) or isolated tumour cells (≤ 0.2 mm) are eligible.

3.1.7 Patients must be ER ≥ 1% and HER2 negative on local testing  

3.1.8 Patients must have an Oncotype DX recurrence score ≤ 25 obtained from testing of breast tumour tissue from a core biopsy or from the surgical specimen.**, ***

** If the patient does not already have Oncotype DX recurrence score, specimen (unstained blocks or slides) must be sent to the Exact Sciences centralized laboratory in Redwood City, California. For Canadian sites, see the MA.39 website https://www.ctg.queensu.ca/trials/breast/ma39 and for US sites, see the CTSU website for the CCTG MA.39 trial for instructions on ordering Oncotype DX test.

*** Oncotype DX testing must be performed on a core biopsy PRIOR to commencement of neoadjuvant endocrine therapy. See ineligibility criterion 3.2.8 for further details on the duration of neoadjuvant endocrine therapy.

3.1.9 Patient must consent to provision of, and investigator(s) must agree to submit to the CCTG Central Tumour Bank, a representative formalin fixed paraffin block of tumour tissue in order that the specific correlative marker assays described in the protocol may be conducted. Where tissue exists but local centre regulations prohibit submission of blocks of tumour tissue, the approval of the CCTG must be sought prior to randomization of the first patient to allow cores (two 2 mm cores of tumour from the block) and slides (20 x 5 micron thick unstained slides) of representative tumour tissue to be substituted. Where tumour tissue is available, failure to submit any tissue samples will result in the patient being considered ineligible.

3.1.10 Patient must consent to provision of samples of blood in order that the specific correlative marker assays described in the protocol may be conducted.

3.1.11 Patients must have had endocrine therapy initiated or planned for ≥ 5 years. Premenopausal women will receive ovarian ablation plus aromatase inhibitor therapy or tamoxifen if adjuvant chemotherapy was not administered. For all patients, endocrine therapy can be given concurrently or following RT.

3.1.12 Patients may or may not have had adjuvant chemotherapy.  

**PLEASE SEE THE CURRENT VERSION OF PROTOCOL FOR FULL ELIGIBILITY LIST** 

Inclusion Criteria:

1. Capable of giving signed informed consent prior to any study procedure.
2. Participant must be at least 18 years or the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the ICF.

3. Histologically confirmed unresectable, locally advanced or metastatic adenocarcinoma of gastric, GEJ, or distal esophagus (distal third of the esophagus) and the following requirement:

   (a) Participants with positive CLDN18.2 expression from archival tumor collected within past 24 months or from a fresh biopsy.

4. Disease progression on or after at least one prior line of treatment (LoT) for advanced or metastatic disease, which included a fluoropyrimidine and a platinum, for advanced or metastatic disease.
5. Must have at least one measurable or evaluable lesion assessed by the Investigator based on RECIST 1.1.
6. ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing.
7. Predicted life expectancy of ? 12 weeks.
8. Adequate organ and bone marrow function
9. Body weight of ? 35 kg.
10. Sex and Contraceptive Requirements

Exclusion Criteria:

1. Participants with known HER2 positive status as defined as IHC 3+ or IHC 2+/ISH + (Cases with HER2: CEP17 ratio ? 2 or an average HER2 copy number ? 6.0 signals/cell are considered positive by ISH). Participants must undergo local (or have had) HER2 testing by IHC/ISH, and the most recent result of HER2 status will be used to determine the eligibility.
2. Participant has significant or unstable gastric bleeding and/or untreated gastric ulcers.
3. CNS metastases or CNS pathology including: epilepsy, seizures, aphasia, or stroke within 3 months prior to consent, severe brain injury, dementia, Parkinson's disease, neurodegenerative diseases, cerebellar disease, severe uncontrolled mental illness, psychosis, CNS involvement of autoimmune diseases.
4. Participant has known clinically significant corneal disease (eg, active keratitis or corneal ulcerations).
5. Persistent toxicities (CTCAE Grade ? 2) caused by previous anticancer therapy, excluding alopecia. Participants with irreversible toxicity that is not reasonably expected to be exacerbated by study intervention may be included (eg, hearing loss).
6. Prior exposure to any ADC with MMAE payload or any CLDN18.2 targeting treatment other than naked monoclonal antibody (eg, CLDN18.2 targeting CAR-T cell therapy, multi-specific antibody including targeting CLDN18.2, etc).

*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)