*DOA and training log required. Please check your site's status.
CURRENT SITES CREDENTIALED:
SJMH, Genesys Hurley, Ascension St. Mary's Saginaw, St. John

*Sparrow is not participating in this trial.

-New diagnosis of DCIS without invasive cancer. Unilateral, bilateral, unifocal, or multifocal DCIS will be eligible, provided that all DCIS meets eligibility criteria
-No prior history of breast cancer (DCIS or invasive cancer) in either breast
-At least age 40 at time of diagnosis
-Must be female
-ECOG PS must be 0-1
-No contraindication for surgery
-Pathologic diagnosis of DCIS within 90 days of registration
--Grade 1/II or ADH/borderline DCIS
--ER+ and/or PR+
--HER2 0, 1+, or 2+ by IHC, if testing is performed
--absence of comedonecrosis
-Must not have concurrent invasive breast cancer
-Must not have mass on exam or imaging at site of DCIS prior to biopsy yielding diagnosis
-Must not have use of investigational cancer agents within 6 weeks prior to dx
-Must not have history of prior tamoxifen, aromatase inhibitor or raloxifene

*This study is only open to SJMH sites.  

Screening Eligibility:
-Participants must have histologically confirmed invasive breast cancer that is metastatic or not amenable for resection or RT with curative intent.
-Patients must have histologically confirmed HER2+ and hormone receptor positive metastatic breast ca.

Randomization Eligibility:
-ECOG PS must be 0-1
-Must have resolution of all acute toxic effects or prior induction anti-HER2-based chemo to no more than grade 1 (except alopecia or other toxicities not considered a safety risk)  
-Patients may or may not have received neo/adjuvant therapy, but must have a disease-free internal from completion of anti-HER2 therapy to metastatic diagnosis of at least 6 months
-Patients must have received an acceptable, standard chemo containing anti-HER2 based induction therapy for the treatment of metastatic breast cancer prior to enrollment. Chemo is limited to a taxane or vinorelbine. Eligible patients are expected to have completed 6 cy of chemo containing anti-HER2 treatment. A minimum of 4 cy is acceptable for patients experiencing significant toxicity. The maximum number of cycles is 8. Patient are eligible as long as they are without evidence of PD.
-Patients must not have prior therapy with any CDK inhibitor.

*DTL Required- Physicians must sign toxicity grid

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

CURRENT SITES CREDENTIALED: Trinity Health IHA ( Ann Arbor, Brighton, Canton, Chelsea) and Livonia

Eligibility Criteria:

3.2.1 Age

Patients must be 5 to 60 years of age at the time of enrollment.

3.2.2 Diagnosis

3.2.2.1 Patients with newly diagnosed untreated histologically confirmed classic Hodgkin lymphoma (cHL) (nodular sclerosis, mixed cellularity, lymphocyte-rich, or lymphocyte-depleted, or not otherwise specified (NOS)) with Stage I or II disease.

3.2.2.2 Patients must have bidimensionally measurable disease (at least one lesion with longest diameter ≥ 1.5 cm).

3.2.2.3 Patients must have a whole body or limited whole body PET scan performed within 42 days prior to enrollment. PET-CT is strongly preferred. PET-MRI allowed if intravenous contrast enhanced CT is also obtained.

3.2.2.4 Pediatric patients (age 5-17 years) must have an upright PA CXR for assessment of bulky mediastinal disease. Adult patients must have either a CXR or CT chest.

3.2.3 Performance Score

• Patients ≥ 18 years must have a performance status corresponding to Zubrod scores of 0, 1 or 2.

• Patients ≤ 17 years of age must have a Lansky performance score of ≥ 50.

3.2.4 Organ Function Requirements

Please note that eligibility criteria and the timing of documentation prior to enrollment differ by age.

3.2.4.2 Adequate liver function* defined as:

• Total bilirubin ≤ 2 x ULN, and

• AST and ALT ≤ 3 x ULN * unless due to Gilbert’s disease, lymphomatous involvement of liver or vanishing bile duct syndrome

3.2.4.3 Adequate cardiac function defined as:

- Shortening fraction of ≥ 27% by echocardiogram (ECHO), MUGA, or functional cardiac imaging scan or

- Ejection fraction of ≥ 50% by radionuclide angiogram, ECHO, MUGA, or cardiac imaging scan. 3.2.4.4 Adequate pulmonary function defined as:

- DLCO ≥ 50% of predicted value as corrected for hemoglobin by pulmonary function test (PFT)

- If unable to obtain PFTs, the criterion is: a pulse oximetry reading of > 92% on room air.

3.2.5 HIV Status

Known HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.

PLEASE SEE THE CURRENT VERSION OF PROTOCOL FOR FULL ELIGIBILITY LIST

***09/05/08: The optional NSABP B-42 Registration Program will close to further enrollment. ***

1. The patient must have consented to participate and must have signed and dated an appropriate IRB-approved consent form that conforms to federal and institutional guidelines.

2. Patients must be female.

3. Patients must have an ECOG performance status of 0 or 1 (0 = fully active, able to carry on all pre-disease performance without restriction; 1 = restricted in physically strenuous activity but ambulatory).

4. Patients must be postmenopausal at the time of randomization. (Note:

Premenopausal or perimenopausal women requiring therapy with luteinizing

hormone-releasing hormone [LHRH] analogs to suppress ovarian function are

not eligible.) For study purposes, postmenopausal is defined as:

? age 56 or older with no spontaneous menses for at least 12 months prior to

study entry, or

? age 55 or younger with no spontaneous menses for at least 12 months prior to

study entry (e.g., spontaneous or secondary to hysterectomy) AND with a

documented estradiol level in the postmenopausal range according to local

institutional/laboratory standards, or

? a prior documented bilateral oophorectomy.

5. The patient must have remained disease-free from the time of initial breast cancer diagnosis until the time of randomization.

6. The primary tumor must have been pathologic or clinical stage I, II, or IIIA

invasive carcinoma of the breast documented by core needle or open biopsy.

(Refer to Coordinator Online in the Members' Area of the NSABP Web site for

TNM nomenclature and staging information.)

7. The primary tumor must have been ER-positive and/or PgR-positive. (Patients

who had a tumor that was considered to be borderline for ER positivity and who

were treated with tamoxifen and/or an AI are eligible for this study.)

8. Patients must have undergone either a lumpectomy with axillary nodal staging

followed by breast radiotherapy or a total mastectomy with axillary nodal

staging. (Acceptable axillary nodal staging procedures include sentinel node

biopsy alone, if sentinel nodes were negative on H&E staining.)

9. The duration of the patient's hormonal therapy following breast cancer diagnosis must have been 57-63 months from the first dose regardless of the number of missed doses. Hormonal therapy must have consisted of an AI or a combination of up to 3 years of tamoxifen followed by an AI. Tamoxifen may not have been given during years 4 and 5 of the 5 years of adjuvant hormonal therapy. Optional Letrozole Registration Program for patients who have not yet

completed 5 years of hormonal therapy: In order to have a predominantly

letrozole-treated population for B-42 study entry, patients who have had a

minimum of 2 years of hormonal therapy and who are currently on tamoxifen

(for up to 3 years) or an AI may be offered letrozole at no cost until they

complete 5 total years of initial adjuvant hormonal therapy. See Appendix A for

instructions on enrolling patients on this optional Letrozole Registration

Program.

10. B-42 randomization must be within 6 months following completion of 5 years of initial adjuvant hormonal therapy.

11. At the time of randomization, the patient must have had the following:

? history and physical exam within 3 months demonstrating no findings

suggestive of recurrent breast cancer;

? bilateral mammogram within 1 year (unilateral if patient had a mastectomy);

? bone mineral density (BMD) testing within 1 year; and

? lipid profile (total cholesterol, LDL-C, HDL-C, and triglycerides) with a total cholesterol value = grade 1 (according to CTCAE v3.0), with or without

cholesterol-lowering therapy.

- within 1 year if the patient has a history of hypercholesterolemia

controlled with cholesterol-lowering therapy and/or therapeutic lifestyle

changes or if the patient has a history of one or more of the following

risk factors for future cardiovascular events: diabetes, hypertension,

obesity, tobacco use, hypertriglyceridemia, documented coronary artery

disease, or family history of premature coronary heart disease.

- within 2 years for all other patients.

Note: For information regarding management of blood cholesterol, refer to

Section 8.1.



Conditions for patient ineligibility

1. History of non-traumatic osteoporotic fracture of wrist, hip, or spine.

2. Diagnosis of contralateral breast cancer including DCIS.

3. Other malignancies unless the patient is considered to be disease-free for 5 or more years prior to randomization, and is deemed by their physician to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, colon carcinoma in situ, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.

4. Sex hormonal therapy, e.g., estrogen- or progesterone-replacement therapy or

oral contraceptives. These patients are eligible only if this therapy is

discontinued prior to randomization. (See Section 7.3 for exceptions.)

5. Therapy with any hormonal agent such as raloxifene for management of

osteoporosis. Patients are eligible only if these medications are discontinued

prior to study entry.

6. Administration of any investigational agent within 30 days before study entry.

 Effective 08/06/18 BAHO/QoL component is closed to accrual

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

-ECOG PS must be 0-1
-Patient must be female
-Patient must have clinically T1-3, N1 breast cancer at the time of diagnosis (before neoadjuvant therapy)
-Patient must have had pathologic confirmation of axillary nodal involvement at presentation (before neoadjuvant therapy) based on either a positive FNA or positive core needle biopsy; documentation of axillary nodal positivity by sentinel node biopsy (before neoadjuvant therapy) is not permitted
-Patients must have had ER analysis performed on the primary breast tumor before neoadjuvant therapy; if negative for ER, assessment of PgR must also be performed
-Patients must have had HER2 testing performed on the primary breast tumor before neoadjuvant chemotherapy; patients who have a primary tumor that is either HER2-positive or HER2-negative are eligible
-Patients must have completed a minimum of 8 weeks of standard neoadjuvant chemotherapy consisting of an anthracycline and/or taxane-based regimen 
-For patients who receive adjuvant chemotherapy after surgery, a maximum of 12 weeks of intended chemotherapy may be administered but must be completed before randomization
-Patients with HER2+ tumors must have received neoadjuvant anti-HER2 therapy, unless medically contraindicated
-At the time of definitive surgery, all removed axillary nodes must be histologically free from cancer 
-Patients are eligible whether there is residual invasive carcinoma in the surgical breast specimen or whether there is evidence of pathologic complete response
-Patients with pathologic staging of ypN0(i+) or ypN0(mol+) are eligible. Patients must not have N2 or N3 disease detected clinically or by imaging. 
-Patient who have undergone either a total mastectomy or a lumpectomy are eligible. Margins must be negative.
-The interval between the last surgery for breast cancer (including re-excision of margins) and randomization must be no more than 70 days; also, if adjuvant chemotherapy was administered, the interval between the last chemotherapy treatment and randomization must be no more than 70 days
-Patients must not have definitive clinical or radiologic evidence of metastatic disease
-Patients must not have T4 tumors including inflammatory breast cancer
-Patients must not have had any radiation therapy for the currently diagnosed breast cancer prior to randomization  or any breast or thoracic RT for any condition. 

Please note: patients who are found to be pathologically node-positive at the time of surgery, based on sentinel node biopsy alone, are candidates for A011202

*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