Radiation Oncology/Breast/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

• B-01 - Thiotepa vs placebo. Short course perioperative. (1958-61)
  • PMID 14062942 (1963, no abstract), PMID 4970947 Full text (1967), 10-year results: PMID 805475 (1975)
• B-02 - Post-mastectomy RT. Radical mastectomy. Randomized to post-op RT, placebo, or TSPA.(1961-68)
  • PMID 4989839 Full text (1970)
• B-03 - Ovarian ablation vs control (1961)

• B-04 - invasive breast (1971-74)
  • axillary dissection vs radiotherapy
  • Chest wall irradiation
  • Original: PMID 326381 Full text (1977), 10-year results: PMID 3883168 (1985), 25-year results: PMID 12192016 Full text (2002)
  • Radiation compliance: PMID 6992972 Full text (1980), "The clinical and biologic significance of medial-central breast cancers": PMID 7284980 Full text (1981)
  • Other:
    • PMID 18029105 (2008) - arm edema
    • 2nd malignancy: PMID 14508821 (2003) - lung ca. PMID 17551308 (2007) - pleural mesothelioma

• B-05 - L-PAM (L-phenylalanine mustard, Melphalan) for node-positive (1972-75)
  • 10-year results: PMID 3519883 (1986)

• B-06 - invasive breast (1976-84)
  • partial mastectomy + XRT vs. mastectomy
  • 5-year results: PMID 3883167 (1985), 8-year results: PMID 2927449 (1989), 12-year results: PMID 7477145 Full text (1995), 20-year results: PMID 12393820 Full text (2002)

• 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-09 - Combination chemotherapy (L-PAM + 5-FU) +/- tamoxifen (1977-81)
  • PMID 7015139 (1981), PMID 2856857 (1986), PMID 3551710 (1987)

• 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-13 - chemotherapy (sequential MTX and 5-FU) for node-negative, ER-negative tumors (1981-88)
  • PMID 2644531 (1989), PMID 1627417 (1992), PMID 8683228 (1996)

• B-14 - tamoxifen for ER+, node-negative tumors (1982-88)
  • Initial results: PMID 2644532 (1989)
  • 2nd randomization (5 yrs vs 10 yrs): PMID 1627417 (1992), PMID 8901851 Full Text (1996), PMID 11333290 (2002)

• 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)
  • PMID 2202791 (1990)

• 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)
  • PMID 2189950 (1990)

• B-17 - DCIS. Lumpectomy + RT (1985-90)
  • Randomized. 818 women with DCIS, SM-. Treated with lumpectomy or lumpectomy + RT 50Gy (no boost)
    • 5-years; 1993 PMID 8292119
    • 12-years; 2005 PMID 15752884

• B-18 - neoadjuvant vs adjuvant chemotherapy (1988-93)
  • original 5 year results (1998): PMID 9704717
  • locoregional disease (1997): PMID 9215816
  • 9 year results (2001): PMID 11773300
  • pathologic examination (2002): PMID 12209710

• B-19 - sequential MF vs CMF; node-negative, ER-negative (1988-90)
  • PMID 8683228 (1996)

• B-20 - chemo + tamoxifen vs tamoxifen alone for node-negative, ER+ tumors (1988-93)
  • 1997: PMID 9390536 Full text

• B-21 - Tamoxifen vs RT vs Tamoxifen/RT for node-negative <=1cm tumors (1989-98)
  • 2002: PMID 12377957
  • Pathobiology: PMID 17896781 (2007)

• 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)
  • PMID 11181655 (2001)

• 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)
  • Protocol design and very early preliminary results: PMID 9213327
  • Preliminary results: PMID 14559892 (2003)
  • Results (2006): PMID 16606972
  • Sentinel node biopsy: PMID 15837984 (2005)

• B-28 - Chemotherapy. AC x 4, Randomized +/- Taxol x 4; node-positive. (1995-98)
  • 2005: PMID 15897552

• 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)
  • PMID 16236738 Full text (2005) (Combined results with NCCTG N9831 trial)
  • Cardiac dysfunction: PMID 16258083 (2005)

• B-32 - sentinal node biopsy vs axillary dissection for clinically node negative (1999-2004)
  • Technical Outcomes: PMID 17851130 (2007)
  • Morbidity: PMID 20648579 (2010)
  • Survival: PMID 20863759 (2010)

• 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
  • PMID 14508821 (2003)
  • From B-04 and B-06

• Pleural Mesothelioma
  • PMID 17551308 (2007)
  • From 11 NSABP trials

"P" trials

• P-1 - Breast Cancer Prevention Trial (1992-7) - Tamoxifen
  • PMID 9747868 (1998), PMID 16288118 (2005)
  • Ancillary: PMID 16418513, 2006 (hormone levels)
• P-2 - STAR (Study of Tamoxifen and Raloxifene) - prevention trial, post menopausal only, 19,000 women
  • PMID 16754727 (2006), Quality of life: PMID 16754728 (2006)

Other NSABP publications

• 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.