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Clinical Trials: Ongoing Trials

Adjuvant Breast Carcinoma

ER = Estrogen Receptor, PR = Progesterone Receptor

TNM Staging: T = Tumor, N = Nodal status, M = Metastasis

Disease Stage

 

Lobular Carcinoma in Situ (LCIS) NONE
Ductal Carcinoma in Situ (DCIS)

NONE

Completion of 5 years of Hormonal Therapy

NSABP B-42: Five years of Letrozole versus Placebo (Can enroll while taking the Letrozole in years 3-5 and will the Letrozole will be provided)

ER & / or PR Positive Nodes Negative

PACCT-1 ONCOTYPE DX Assay

Recurrance Score <11 Hormonal therapy, Recurrence Score 11-25 Hormonal Therapy versus Chemotherapy / Hormonal therapy, Recurrence Score > 25 Hormonal Therapy / Chemotherapy

Stage I / II/ III CTSU S0307: Zolendronic Acid versus Clodronate versus Ibandronate

Stage 0, I, or II ER/PR Negative--receiving 3 - 8 months of an alkylating agent

Pre-Menopausal Only--ECOG S0230 Hormonal treatment during chemotherapy to reduce ovarian failure following chemotherapy
Stage 0,I or II (tumor must be 3cm or smaller)—Must have had prior lumpectomy, up to 3 axillary nodes can be histologically positive NSABP B-39: Whole Breast Irradiation (25 treatments in 5 weeks) versus Partial Breast Irradiation (10 treatments in 5 days)

Any T, Any N, M0 ER and/or PR positive, must be 6 months from chemotherapy completion (if given)--PRE-MENOPAUSAL WOMEN ONLY

CTSU IBSCG 24-02: Tamoxifen for 5 years versus Ovarian Function Suppression (either using drugs / Radiation Therapy / surgery) plus Tamoxifen for 5 years versus Ovarian Function Suppression plus Exemestane for 5 years

T1a - 3, N0 - 3

ER / PR Negative

HER2 Negative

Bo20289 BEATRICE: Chemotherapy (Physician Choice) plus Bevacizumab

T1-3, N0-3 and HER2 Positive

If Node Negative, must have one of the following:

Tumor size > 2cm

ER / PR negative

Histologic &/or nuclear grade 2 or 3

Age < 35 years

NSABP B-44 (BETH): Docetaxel + Carboplatin + Trastuzumab (every 3 weeks for 6 cycles. This is given with or without Bevacizumab. Followed by continued Trastuzumab for a complete year of treatment (if Bevacizumab) was given initial, that will continue also for the entire year.

HER 2 positive

Node positive

If Node Negative, tumor size must be > / = 1cm

Prior treatment with at least 4 cycles of an Anthracycline

CTSU N063D (ALTTO) : After the inital chemotherapy the following will occur:

Tratuzumab every 3 weeks for 52 weeks versus Lapatinib orally for 52 weeks versus Tratuzumab every 3 weeks for 12 weeks, then 6 weeks off and then Lapatinib orally for 34 weeks versus Tratuzumab every 3 weeks and Lapatinib orally for 52 weeks.

If Paclitaxel is given, it will be weekly for the first 12 weeks. During this time, the Tratuzumab will also be given weekly.

HER 2 negative & must have one of the following:

At least one node positive

ER negative & tumor size > / = 1cm

ER Positive & tumor size > / = 5cm

ER positive & tumor size < / = 1cm, but < 5cm with a recurrence score of > / = 11

ECOG E5103 Adriamycin + Cytoxan (either every 2 weeks or every 3 weeks) plus Bevacizumab / placebo (4 cycles) followed by Paclitaxel plus Bevacizumab / placebo (4 Cycles). One group will continue the Bevacizumab every 3 weeks for a total of 10 more cycles.

Core biopsy only & Greater than or equal to 2.0cm tumor size & HER2 Negative

 

Core biopsy only & Greater than or equal to 2.0cm tumor size & HER2 Positive

HER2+, locally advanced-NeoAdjuvant OR Stage III after surgery

NSABP B-40: Docetaxel + Adriamycin / Cytoxan (AC) with or without Bevacizumab Versus Docetaxel + Capecitabine + AC with or without Bevacizumab Versus Docetaxel + Gemzar + AC with or without Bevacizumab, then surgery and continued Bevacizumab if received before.

NSABP B-41: Adriamycin + Cytoxan (AC) followed by Trastuzumab + Lapatinib versus + Lapatinib + weekly Paclitaxel

NSABP FB-05 Epirubicin + Cyclophosphamide, then Docetaxel + Herceptin + Bevacizumab

Stage II / III, ER+, Postmenopausal--NeoAdjuvant CTSU Z1031: 16 weeeks versus 18 weeks of Exemestane, Letrozole or Anastroxole
First local and/or regional recurrence NSABP B-37: Observation with or without Radiation, Hormonal therapy, and/or Herceptin versus Chemotherapy (selected by the physician) with or without Radiation, Hormonal therapy, and/or Herceptin


West Michigan Cancer Center • 200 North Park Street • Kalamazoo, MI 49007 • 269-382-2500