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Table 1. Summary of trials
|
Study Follow-up Quality |
Population | Intervention* | Comparator* |
|---|---|---|---|
| Clodronate | |||
|
Diel 200821,35 Median 8.5yr follow-up Fair |
Women with T1-4, N0-2 breast cancer, no distant metastases who received adjuvant endocrine therapy or chemotherapy with or without radiotherapy | Clodronate 1600mg/d for 2yrs (N=157) | Standard care for 2yrs (N=145) |
|
McCloskey 20105 2yr follow-up Fair |
Women with primary breast cancer without metastasis having chemotherapy, endocrine therapy and/or radiotherapy, according to local protocols | Clodronate 1600mg/d for 2yrs (N=419) | Placebo for 2yrs (N=432) |
|
Saarto 20086 10yr follow-up Fair |
Pre/postmenopausal women with breast cancer who received postoperative radiotherapy; premenopausal women who received chemotherapy |
Premenopausal: Postmenopausal: |
Premenopausal: Postmenopausal: |
| Ibandronate | |||
|
ARIBON7 2yr follow-up Fair |
Osteopenic, postmenopausal women with ER+ breast cancer who received anastrozole | Ibandronate 150mg every 4wks for 2yrs (N=25) | Placebo every 4wks for 2yrs (N=25) |
| Pamidronate | |||
|
Kristensen 20088 10yr follow-up (4yr BMD) Fair |
Women with no distant metastases and either: 1) premenopausal, grade 2-3 breast cancer ≤5cm without lymph node metastasis; 2) premenopausal, HR-ve/ unknown breast cancer & axillary lymph node metastases or primary tumour >5cm; 3) postmenopausal, HR-ve breast cancer & axillary lymph node metastasis or primary tumour >5cm Patients received adjuvant chemotherapy; locoregional radiotherapy was given according to local guidelines, and endocrine therapy was avoided |
Pamidronate 150mg twice daily for 4yrs (N=460) | Standard care for 4yrs (N=493) |
| Risedronate | |||
|
Hines 2009a25 1yr follow-up Good |
Premenopausal women with stage I-IIIb breast cancer with adjuvant/neoadjuvant chemotherapy scheduled with or without tamoxifen | Risedronate 35mg weekly for 1yr (N=108) | Placebo weekly for 1yr (N=108) |
|
REBBeCa9,26-28 2yr follow-up Good |
Women with breast cancer, <8yrs postmenopausal, after chemotherapy with or without endocrine therapy | Risedronate 35mg weekly for 2yrs (N=43) | Placebo weekly for 2yrs (N=44) |
|
SABRE10 2yr follow-up Good |
Postmenopausal women with non-metastatic breast cancer, moderate fracture risk with anastrozole scheduled | Risedronate 35mg weekly for 2yrs (N=77) | Placebo weekly for 2yrs (N=77) |
| Zoledronic acid | |||
|
ABCSG-1211,22-23 Median 5yr follow-up (5yr BMD) Fair |
Premenopausal women with stage I-II ER+/PR+ breast cancer, <10 positive lymph nodes, standard therapy with goserelin scheduled Preoperative chemotherapy was allowed however no patients received adjuvant chemotherapy; postoperative radiotherapy was given according to local guidelines |
GTZ: Goserelin 3.6mg s.c. every 4wks & tamoxifen 20mg/d & ZA IV 8mg every 4wks for 3yrs (N=449)§ GAZ: Goserelin 3.6mg s.c. every 4 wks & anastrozole 1mg/d & ZA IV 8mg every 4wks for 3yrs (N=450)§ |
GT: Goserelin 3.6mg s.c. every 4 wks & tamoxifen 20mg/d for 3yrs (N=451) GA: Goserelin 3.6mg s.c. every 4wks & anastrozole 1mg/d for 3yrs (N=453) |
|
Hershman 201012 2yr BMD follow-up; 1yr AEs, recurrence Fair |
Premenopausal women with non-metastatic breast cancer receiving chemotherapy | ZA IV 4mg every 3mths for 1yr (N=57) | Placebo for 1yr (N=57) |
|
Hines 2009b24 2yr follow-up Fair |
Postmenopausal women with stage I-IIIa ER+/PR+ breast cancer without metastasis, ≤6yrs tamoxifen completed | Letrozole 2.5mg/d for 5yrs + upfront† ZA IV 4mg every 6mths for 5yrs or until recurrence (N=279) | Letrozole 2.5mg/d for 5yrs + delayed‡ ZA IV 4mg every 6mths for 5yrs or until recurrence (N=279) |
|
Z-FAST17 3yr follow-up Fair |
Postmenopausal women with stage I-IIIa ER+/PR+ breast cancer | Letrozole 2.5mg/d for 5yrs + upfront† ZA IV 4mg every 6mths for 5yrs (N=301) | Letrozole 2.5mg/d for 5yrs + delayed‡ ZA IV 4mg every 6mths for 5yrs (N=301) |
|
ZO-FAST18 1yr follow-up Fair |
Postmenopausal women with stage I-IIIa ER+/PR+ breast cancer | Letrozole 2.5mg/d for 5yrs + upfront† ZA IV 4mg every 6mths for 5yrs (N=532) | Letrozole 2.5mg/d for 5yrs + delayed‡ ZA IV 4mg every 6mths for 5yrs (N=533) |
Abbreviations: AE = adverse event; BMD = bone mineral density; ER+ = oestrogen receptor-positive; GA = goserelin & anastrozole; GAZ = goserelin & anastrozole & zoledronic acid; GT = goserelin & tamoxifen; GTZ = goserelin & tamoxifen & zoledronic acid; HR- = hormone receptor-negative; IV = intravenous; PR+ = progesterone receptor-positive; s.c. = subcutaneous; ZA = zoledronic acid
*administered orally unless otherwise specified; §protocol amendments, after 254 patients had been enrolled, reduced the dose of intravenous zoledronic acid from 8mg every 4 weeks to 4mg every 6 months; †administered immediately after random assignment; ‡administered when either post-baseline lumbar spine or total hip T score decreased to less than -2.0 or a non-traumatic clinical fracture occurred
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