Patients in BCIRG-005/006/007 trials were screened for enrollment in one of two
central laboratories by using HER2 gene amplification status
determined by FISH as an enrollment criterion4 (link),19 (link),21 (link) (Fig 1 ). Those
patients whose breast cancers were HER2 amplified were eligible for
BCIRG-006 or 007, whereas those whose breast cancers were not HER2amplified were eligible for BCIRG-005 (Fig 1 ).
Criteria for amplified and not amplified that were initially used to screen for entry
to these trials are summarized below and in the Data Supplement.
BCIRG-006 trial (n = 3,222) is a randomized, three-arm study of adjuvant chemotherapy
with or without trastuzumab in patients with HER2-amplified stage I
to III breast cancer who were accrued between April 2001 and March 2004.4 (link) Therapy in the control arm was adjuvant
anthracycline, cyclophosphamide, and docetaxel (AC-T) with or without hormonal
therapy depending on tumor estrogen receptor and progesterone receptor status at site
investigator discretion. Therapy in the two experimental arms involved trastuzumab
(H) with patients randomly assigned to either standard AC-T adjuvant chemotherapy or
nonanthracycline chemotherapy with docetaxel and a platinum salt, again, with or
without hormonal therapy depending on tumor estrogen receptor and progesterone
receptor status. This trial demonstrated significant improvement in DFS for both
trastuzumab-containing treatment arms compared with control AC-T adjuvant
chemotherapy alone. Outcomes are summarized in the Data Supplement and reported
elsewhere.4 (link),26 BCIRG-005 clinical trial (n = 3,298) is a randomized study of concurrent (taxotere,
adriamycin, and cyclophosphamide) or sequential (AC-T) adjuvant
anthracycline-containing chemotherapy in patients with HER2-normal
(nonamplified) stage II and III breast cancer who were accrued from August 2000 to
February 2003. This trial demonstrated that sequential and combination regimens that
incorporated three drugs were equally efficacious but differed significantly in
toxicity profile. Clinical outcomes are summarized in the Data Supplement, and trial
details are reported elsewhere.19 (link),25 (link)BCIRG-007 trial (n = 263), a randomized phase III trial of docetaxel and trastuzumab
compared with docetaxel, carboplatin, and trastuzumab in women with
HER2-amplified metastatic breast cancer,24 (link) was screened for
HER2 status by FISH concurrently with BCIRG-005 and BCIRG-006.
Data for HER2 gene amplification and expression are included in the
current study; however, outcome information is not included as this trial had no
control, nontrastuzumab treatment arm (Data Supplement).
central laboratories by using HER2 gene amplification status
determined by FISH as an enrollment criterion4 (link),19 (link),21 (link) (
patients whose breast cancers were HER2 amplified were eligible for
BCIRG-006 or 007, whereas those whose breast cancers were not HER2amplified were eligible for BCIRG-005 (
Criteria for amplified and not amplified that were initially used to screen for entry
to these trials are summarized below and in the Data Supplement.
BCIRG-006 trial (n = 3,222) is a randomized, three-arm study of adjuvant chemotherapy
with or without trastuzumab in patients with HER2-amplified stage I
to III breast cancer who were accrued between April 2001 and March 2004.4 (link) Therapy in the control arm was adjuvant
anthracycline, cyclophosphamide, and docetaxel (AC-T) with or without hormonal
therapy depending on tumor estrogen receptor and progesterone receptor status at site
investigator discretion. Therapy in the two experimental arms involved trastuzumab
(H) with patients randomly assigned to either standard AC-T adjuvant chemotherapy or
nonanthracycline chemotherapy with docetaxel and a platinum salt, again, with or
without hormonal therapy depending on tumor estrogen receptor and progesterone
receptor status. This trial demonstrated significant improvement in DFS for both
trastuzumab-containing treatment arms compared with control AC-T adjuvant
chemotherapy alone. Outcomes are summarized in the Data Supplement and reported
elsewhere.4 (link),26 BCIRG-005 clinical trial (n = 3,298) is a randomized study of concurrent (taxotere,
adriamycin, and cyclophosphamide) or sequential (AC-T) adjuvant
anthracycline-containing chemotherapy in patients with HER2-normal
(nonamplified) stage II and III breast cancer who were accrued from August 2000 to
February 2003. This trial demonstrated that sequential and combination regimens that
incorporated three drugs were equally efficacious but differed significantly in
toxicity profile. Clinical outcomes are summarized in the Data Supplement, and trial
details are reported elsewhere.19 (link),25 (link)BCIRG-007 trial (n = 263), a randomized phase III trial of docetaxel and trastuzumab
compared with docetaxel, carboplatin, and trastuzumab in women with
HER2-amplified metastatic breast cancer,24 (link) was screened for
HER2 status by FISH concurrently with BCIRG-005 and BCIRG-006.
Data for HER2 gene amplification and expression are included in the
current study; however, outcome information is not included as this trial had no
control, nontrastuzumab treatment arm (Data Supplement).
