Radiation Oncology/Breast/NSABP trials

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Front Page: Radiation Oncology | RTOG Trials

Breast: Main Page | Staging | Breast Overview | Prevention | Benign | DCIS | LCIS | Paget's | Phyllodes tumor | Early stage | Advanced stage | Post mastectomy | Inflammatory | Partial breast irradiation | Regional lymphatics | Hormonal therapy | Chemotherapy | RT technique | Recurrence | Toxicity of RT | Randomized | NSABP trials

The National Surgical Adjuvant Breast and Bowel Project (NSABP):

See other NSABP trials (on Wikibooks).
See the NSABP web page and list of NSABP publications.

"B" trials[edit]

  • B-01 - Thiotepa vs placebo. Short course perioperative. (1958-61)
  • B-02 - Post-mastectomy RT. Radical mastectomy. Randomized to post-op RT, placebo, or TSPA.(1961-68)
  • B-03 - Ovarian ablation vs control (1961)


  • B-05 - L-PAM (L-phenylalanine mustard, Melphalan) for node-positive (1972-75)
  • B-07 - L-PAM vs L-PAM + 5-FU for node-positive (1975-76)
  • B-08 - L-PAM + 5-FU vs L-PAM + MTX (1976-77)
  • B-10 - Combination chemotherapy +/- C.parvum and hydrocortisone (1977-81)
  • B-11 - L-PAM + 5-FU +/- Adriamycin for node-positive and ER-negative tumors (1981-84)
  • B-12 - Same as B-11 but Tamoxifen used in both arms; ER-positive tumors (1981-84)
  • B-15 - short-intensive AC chemotherapy with or without reinduction CMF vs conventional CMF; node-positive; age < 50, or age 50-59 and PR negative (1984-88)
  • B-16 - tamoxifen alone vs chemo+tam (L-PAM + 5-FU + Adriamycin) vs short-intensive AC + Tamoxifen; node-positive; age 50-59 and PR positive, or age 60-70 (1984-89)
  • B-17 - DCIS. Lumpectomy + RT (1985-90)
    • Randomized. 818 women with DCIS, SM-. Treated with lumpectomy or lumpectomy + RT 50Gy (no boost)
  • B-19 - sequential MF vs CMF; node-negative, ER-negative (1988-90)
  • B-20 - chemo + tamoxifen vs tamoxifen alone for node-negative, ER+ tumors (1988-93)
  • B-21 - Tamoxifen vs RT vs Tamoxifen/RT for node-negative <=1cm tumors (1989-98)
  • B-22 - AC dose intensification; node-positive (1989-91)
  • B-23 - Two-by-two randomization: CMF chemo, CMF + tamoxifen, AC chemo, AC + tamoxifen for node-negative, ER-negative (1991-98)
  • B-24 - Tamoxifen for DCIS (1991-94)
    • PMID 10376613 (1999)
    • No PMID (Abstract) "Estrogen receptor expression as a predictive marker of the effectiveness of tamoxifen in the treatment of DCIS: findings from NSABP Protocol B-24." Allred DC et al. Breast Cancer Res Treat 2002;76(suppl):S36.
  • B-25 - Dose intensification with AC chemotherapy + G-CSF; node-positive (1992-94)
  • B-26 - Taxol 3 hour infusion vs 24 hour infusion; metastatic or locally advanced (1994-96)
  • B-27 - taxane (Taxotere either before or after surgery) or no taxane after neoadjuvant AC (1995-2000)
  • B-28 - Chemotherapy. AC x 4, Randomized +/- Taxol x 4; node-positive. (1995-98)
  • B-29 - Tamoxifen +/- Octreotide, or Tamoxifen + Chemo +/- Octreotide; node-negative, ER-positive (1997-99)
  • B-30 - AC followed by Taxol, vs AT, vs ATC; node-positive (1999-2004)
  • B-31 - AC-T +/- Trastuzumab; node-positive, overexpress her-2 (2000-2005)
  • B-32 - sentinal node biopsy vs axillary dissection for clinically node negative (1999-2004)
  • B-33 - after 5 years of Tamoxifen, randomize to +/- Exemestane (2001-2003)
    • stopped early due to benefit seen in concurrent MA.17 trial, which was also stopped early
  • B-34 - Clondronate vs placebo in pts receiving chemo and/or hormones or no adjuvant therapy (2000-2004)
  • B-35 - DCIS, Tamoxifen vs Arimidex (2003-)
    • open trial
  • B-36 - FEC x 6 cycles vs AC x 4 cycles; node-negative (2004-)
    • open trial
  • B-37 - IBCSG trial 27-02 - adjuvant chemotherapy following resection for locoregional relapse (2005-)
    • open trial
  • B-38 - TAC (docetaxel, doxorubicin, cyclophosphamide) vs dose-dense AC/T (taxol) vs dose-dense AC/T+Gemzar in node-positive. (2004-)
    • open trial
  • B-39 / RTOG 04-13 - randomized trial of partial-breast vs whole-breast irradiation for Stage 0, I, or II (2005-)
    • open trial
  • B-40 - Neoadjuvant. Randomized to 1 of 6 arms: (Group 1-3: docetaxel, docetaxel + capecitabine, docetaxel + gemcitabine) followed by AC. Randomized to +/- bevacizumab (1A=docetaxel w/o bev, 1B=docetaxel w/ bev, etc.)



NSABP publications based on findings from 2 or more trials:

  • Tumors <= 1 cm, Node Negative
    • 2001 PMID 11208880 -- "Prognosis and treatment of patients with breast tumors of one centimeter or less and negative axillary lymph nodes." (Fisher B, J Natl Cancer Inst. 2001 Jan 17;93(2):112-20.)
      • From NSABP B-06, B-13, B-14, B-19, and B-20. N=1259 (1024, ER+; 235, ER-). Treatments were randomized according to the trial.
      • ER(-): Overall 8-yr RFS 81% vs 90%(+Chemo). Survival 93% vs 91% (NS).
      • ER(+): RFS 86% vs 93%(+Tam) vs 95% (+Tam+Chemo). Survival 90% vs 92% vs 97%.
      • Overall mortality 8% (one-half of all deaths were attributed to breast cancer)
      • Conclusion: Adjuvant therapy should be considered in this population
  • The Incidence of Lung Carcinoma After Surgery for Breast Carcinoma With and Without Postoperative Radiotherapy

"P" trials[edit]

Other NSABP publications[edit]

  • 1991: PMID 1847652 Full text (PDF) — "A biological perspective of breast cancer: contributions of the National Surgical Adjuvant Breast and Bowel Project clinical trials." Fisher B. CA Cancer J Clin. 1991 Mar-Apr;41(2):97-111.
    • Summary of 22 NSABP breast trials to date.
  • 1999: PMID 10445015 Full text — "Highlights from recent National Surgical Adjuvant Breast and Bowel Project studies in the treatment and prevention of breast cancer." Fisher B et al. CA Cancer J Clin. 1999 May-Jun;49(3):159-77.