Clinical Trials – Breast Cancer

Clinical Trials – Breast Cancer

Clinical Trials – Breast Cancer

BREAST PROTOCOLS: Neoadjuvant

1. ACOSOG Z1031 (temporarily closed to accrual)
Neoadjuvant Hormonal Therapy
Eligibility: clinical stage T2-T4c, any N, M0; ER+ tumor with Allred score of 6, 7 or 8; postmenopausal; surgical resection is the goal; performance status 0-2: RX: Exemestane 25 mg/day vs Letrozole 2.5 mg/day vs Anastrozole 1
mg/day. Pts will have breast biopsy at 2-4 wks for Ki67 testing. Pts with Ki67 of 10 will have chemo or immediate surgery. (NO DRUG SUPPLIED)

2. CALGB 40601
Clinical Stage II-III; HER2 Positive
Eligibility: breast tumor must be at least 1 cm by clinical or radiographic msmt; multicentric or bilateral dz is OK; no prior treatment for this cancer; performance status 0-1; men OK: Rx: Taxol/Herceptin weekly + Lapatinib po qd x 16 weeks versus Taxol/Herceptin weekly x 16 weeks. (LAPATINIB SUPPLIED) Companion study: SCUSF 0806 (with Herceptin).

3. CALGB 40603 (temporarily closed to accrual)
Clinical Stage IIA-IIIA; Triple Negative (ER/PR/HER2)
Eligibility: histologic dx by core or incisional bx; measurable dz >/= 1 cm; pt must agree to pretreatment research biopsies; no prior chemo, hormonal therapy or RT for this cancer; performance status 0-1: Rx: Paclitaxel followed by ddAC +/- Bevacizumab vs Paclitaxel + Carboplatin followed by ddAC +/- Bevacizumab. (BEVACIZUMAB SUPPLIED).

4. SWOG 0800
HER2-negative Inflammatory or Locally Advanced
Eligibility: women with stage IIIb or stage IIIa/IIb unresectable dz; no prior chemo, biologic therapies or RT for breast cancer within 5 yrs; prior hormonal Rx okay but must D/C 7 days prior to protocol Rx; performance status 0-2: Rx: Bev + nab-paclitaxel x 12 wks –> AC + PEG-G q 2 wks x 6 versus Nab-paclitaxel q wk x 12 –> AC + PEG-G q 2 wks x 6 versus AC + PEG-G q 2 wks x 6 –> nabj-paclitaxel x 12 wks. (BEVACIZUMAB AND NAB-PACLITAXEL SUPPLIED)

BREAST PROTOCOLS: Stages 0-II

1. NSABP B-39: (RTOG 0413)
Stages 0 – II Treated by Lumpectomy (Closed to the following low risk groups: women >/= 50 yrs with DCIS only or with node negative, hormone positive invasive cancer)
Eligibility: tumor < 3.0 cm; no more than 3 positive nodes; no bilateral dz; must enroll prior to start of adj chemo and within 42 days of last surgery for breast cancer: RX: Whole breast irradiation versus partial breast irradiation (approved for use at Doctors Medical Center and East Bay Radiation Oncology Center only).

2. NSABP B-43
HER2-positive DCIS
Eligibility: tumors must be HER2 positive by centralized testing (pts must agree to centralized HER2 testing pre-entry); tumor completely removed by lumpectomy; axillary staging not required but if done must be node-negative; enroll

3. SWOG 0812
Premenopausal Women at High Risk for Breast Cancer
Eligibility: Premenopausal, age 18-50; DCIS/LCIS dx or mutation in BRCA1 / BRCA2 / PTEN / TP53 or Modified Gail/CARE model risk at 5 years > 1.67%; available breast for imaging (not previously irradiated); no known invasive breast cancer; no breast implants; option for breast biopsy. RX: Cholecalciferol + vitamin D3 x 12 months versus identical Placebo + vitamin D3 x 12 months. (DRUGS PROVIDED)

BREAST PROTOCOLS: Stages I-III

1. CTSU MA.32
Post Surgery and/or Chemotherapy
Eligibility: invasive breast cancer completely resected within 12 months of enrollment; pT1c-3; pN0-3; M0 (refer to protocol section 5.1.4 for specific details); no clinical T4; Her2 +/- ok; completed surgery and/or chemo at least 4 wks prior to enrollment; bilateral breast CA ok if synchronous; performance status 0-2; age >18 <75 and at least 5 year life expectancy.
Rx: Metformin x 5 yrs versus identical Placebo x 5 yrs. (DRUG SUPPLIED)

2. NSABP B-47
Node Positive or High Risk Node Negative and HER2-low
Eligibility: Node pos. If node neg, must have one of the following: pT2 and ER/PgR neg; or pT2 and ER + (PgR +/-) and either grd 3 hist or Oncotype RS > 25; Must be HER2 low: IHC 1+ or 2+; FISH < 2.0. Enroll w/in 84 days of last surgery. Bilateral or inflammatory CA not eligible. Chemo choice: Docetaxel + Cyclophosphamide (TC) or Adriamyacin+Cyclophosphamide (AC) > wkly Taxol (T). RX: TC or AC > wkly T versus TC + Trastuzumab or AC > T + Trastuzumab (TRASTUZUMAB SUPPLIED)

3. SWOG 1007
Node-pos (1-3 nodes); ER/PgR Positive; HER2 Neg; RS < 25
Eligibility: Node pos (1-3 nodes); ER and/or PgR pos; HER2 Neg; If Oncotype DX RS known and < 25, eligible to register to step 2 (w/in 84 days after surgery); If no Oncotype DX test performed yet, must submit tissue for testing between 28 days and no later than 56 days after surgery; Performance status: 0-2; No prior treatment for this cancer; Metastatic or inflammatory not eligible; Men not eligible. RX: Oncotype DX Recurrence Score < 25 then Randomize: Chemo + Endocrine therapy versus Endocrine therapy (no chemo).

4. SWOG 0221
Node Positive and High-risk Node Negative (see protocol for risk criteria)
Eligibility: Stage I-III, synchronous bilat dz OK(w/in 1 month); T4 tumors not OK; HER2-positive tumors OK; men OK; no CHF or active angina; enroll w/in 84 days of surgery: RX: AC + PEG-G x 4 followed by q 2 wk T + PEG-G x 6 versus AC + PEG-G x 4 followed by weekly T x 12 versus AC + G x15 followed by q 2 wk T + PEG-G x 6 versus AC + G x15 followed by weekly T x 12. (G-CSF SUPPLIED- contact Amgen for financial assistance with PEG-G if needed)

BREAST PROTOCOLS: Locally Advanced/Recurrent/Metastatic

1. CTSU E2108
Intact Primary Tumor with Metastatic Breast Cancer
Eligibility: Intact primary Br CA (not recurrent); CNS mets eligible (as long survival > 6 mos); at least one site of metastatic disease; Males eligible; prior non-invasive DCIS eligible. RX: (step 1) Optimal systemic therapy. If CR, PR or SD à (step 2 randomize): continued systemic therapy versus surgery + RT (primary tumor) > systemic therapy. (NO DRUGS SUPPLIED)

2. CTSU N0733
HER2-positive and Previously Treated with Trastuzumab
Eligibility:locally adv (T4 & stg IIIb or IIIc) or metastatic dz; only 1 prior chemo regimen containing Trastuzumab with an anthracycline and/or a taxane in the adj or adv/met setting; unlimited prior hormonal Rx okay; measurable dz by RECIST; performance status 0 – 2; men okay: Rx: Capecitabine and Lapatinib +/- IMC-A12. (IMC-A12 and LAPATINIB SUPPLIED)

3. SWOG 0800
HER2-negative Inflammatory or Locally Advanced
Eligibility: women with stage IIIb or stage IIIa/IIb unresectable dz; no prior chemo, biologic therapies or RT for breast cancer within 5 yrs; prior hormonal Rx okay but must D/C 7 days prior to protocol Rx; performance status 0-2: Rx: Bev + nab-paclitaxel x 12 wks –> AC + PEG-G q 2 wks x 6 versus Nab-paclitaxel q wk x 12 –> AC + PEG-G q 2 wks x 6 versus AC + PEG-G q 2 wks x 6 –> nabj-paclitaxel x 12 wks. (BEVACIZUMAB AND NAB-PACLITAXEL SUPPLIED)

BREAST PROTOCOLS: Surgical

1. ACOSOG Z1071 (temporarily closed to accrual)
Node Positive Breast Cancer (T1-4, N1-2, M0)
Eligibility: positive FNA or core bx of axillary node (prior to neoadj Rx); planned or completed neoadj chemo; no prior ipsilateral axillary surgery or/excisional biopsy or treatment of hidradenitis; performance status 0-1: Surgery: SLN and ALND

BREAST PROTOCOLS: Radiation (RTOG)
1. RTOG 0413 (NSABP B-39)
Stages 0 – II Treated by Lumpectomy
(Closed to the following low risk groups: women >/= 50 yrs with DCIS only or with node negative, hormone positive invasive cancer)
Eligibility: tumor < 3.0 cm; no more than 3 positive nodes; must enroll prior to start of adj chemo and within 42 days of last surgery for breast cancer: RX: Whole breast irradiation versus partial breast irradiation.

Abbreviations:
CALGB = Cancer and Leukemia Group B
CTSU = Cancer Trials Support Unit
ECOG = Eastern Cooperative Oncology Group
NCI = National Cancer Institute
NSABP = National Surgical Adjunct Breast and Bowel Project
RTOG = Radiation Therapy Oncology Group
SCUSF = SunCoast CCOP Research Base
SWOG = Southwest Oncology Group
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