1. San Antonio Breast Cancer Symposium. December 6-10. 2016
Adjuvant Ibandronate in early breast cancer First results of the TEAM Iib trial
Disclosures
Prof dr. S.C. Linn, MD PhD:
Unrestricted research grant from Roche for the Triple B study
Advisory board Roche for bevacizumab
in breast cancer (paid to institution)
Prof dr. C.J.H van de Velde, MD PhD:
Unrestricted grant from Pfizer and Roche for the TEAM IIB trial
Other authors: no financial or other conflicts of interest to report
The study was supported with
an unrestricted research grant by Roche & Pfizer
Disclosures others?
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2. San Antonio Breast Cancer Symposium. December 6-10. 2016
BOOG
San Antonio Breast Cancer Symposium. December
Adjuvant Ibandronate in postmenopausal women with early breast cancer First results of the TEAM Iib trial S.B. Vliek1; E. Meershoek-Klein Kranenbarg2 ; A.G.J. van Rossum1; B.C. Tanis3; H. Putter2; A.W.G. van der Velden4; M.P. Hendriks5 ; A. van Bochove6; Y. van Riet7; A.E. van Leeuwen-Stok8; J.R. Kroep2; J.W.R. Nortier2; V.C.G. Tjan-Heijnen9; C.J.H. van de Velde2; S.C. Linn Netherlands Cancer Institute, Amsterdam; 2Leiden University Medical Center, Leiden; 3Groene Hart Ziekenhuis, Gouda; 4Martini Ziekenhuis, Groningen; 5Northwest Clinics, Alkmaar; 6Zaans Medisch Centrum, Zaandam. 7Catharina Ziekenhuis, Eindhoven; 8Dutch Breast Cancer Research Group, Amsterdam. 9Maastricht University Medical Center, Maastricht Netherlands.
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3. Adjuvant Ibandronate in early breast cancer Why bisphosphonates
San Antonio Breast Cancer Symposium. December
BOOG
San Antonio Breast Cancer Symposium. December
Adjuvant Ibandronate in early breast cancer Why bisphosphonates
Interaction between
tumor cell & bone
Osteoclasts  bone breakdown
Osteoblasts  bone formation
1EBCTCG. Lancet 2015; 386: Nakamura. Cell 2007; 130: 811–23
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4. Adjuvant Ibandronate in early breast cancer Why bisphosphonates
San Antonio Breast Cancer Symposium. December
BOOG
San Antonio Breast Cancer Symposium. December
Adjuvant Ibandronate in early breast cancer Why bisphosphonates
Interaction between
tumor cell & bone
Bisphosphonate
(e.g. ibandronate)
1EBCTCG. Lancet 2015; 386: Nakamura. Cell 2007; 130: 811–23
This presentation is the intellectual property of the author/presenter. Contact them at for permission to reprint and/or distribute.

5. Adjuvant Ibandronate in early breast cancer Why bisphosphonates
San Antonio Breast Cancer Symposium. December
BOOG
San Antonio Breast Cancer Symposium. December
Adjuvant Ibandronate in early breast cancer Why bisphosphonates
Interaction between
tumor cell & bone
Meta-analysis1
26 trials, > women
Moderate improvement
breast cancer survival
postmenopausal women
ibandronate
1EBCTCG. Lancet 2015; 386: Nakamura. Cell 2007; 130: 811–23
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6. San Antonio Breast Cancer Symposium. December 6-10. 2016
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San Antonio Breast Cancer Symposium. December
San Antonio Breast Cancer Symposium. December
Team Iib
Adjuvant
Endocrine therapy ≥5y +
3 years of ibandronate
50mg once daily
tamoxifen  exemestane
or examestane without switch
follow-up of 10 year
Post-menopausal women
Early breast cancer (no metastasis)
Hormone receptor positive
Surgery
(± radiotherapy and/or chemotherapy)
age, time from surgery to randomization, (neo)adjuvant chemotherapy, hormone receptor status, HER2 overexpression, grade, T-stage, N-stage, center
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7. Study conduct Enrollment end study endpoints
San Antonio Breast Cancer Symposium. December
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San Antonio Breast Cancer Symposium. December
Study conduct Enrollment end study endpoints
Patients from 37 Dutch hospitals ( )
Slower accrual than expected  protocol change
Enrolled 1116 women, equally randomised
Standard treatment (control group)
Standard treatment with ibandronate (ibandronate group)
Endpoints
Disease free survival (DFS) at 3 years
(any breast cancer recurrence, other malignant tumor, mortality)
Time to and rate of bone metastases as first event
Safety and toxicity
Local / regional / distant relapse, second primary breast cancer (including contralateral breast cancer), or death
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8. First results not all patients completed ibandronate yet
San Antonio Breast Cancer Symposium. December
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San Antonio Breast Cancer Symposium. December
First results not all patients completed ibandronate yet
Median follow-up of 4.6 years
20 patients never started, 73 are still on ibandronate
Adherance to ibandronate  67% at 3 years
Baseline characteristics are well balanced
Total DFS events: 149
Control
group
Ibandronate group
Mortality
All causes 47 48
Breast cancer
29 (61.7%)
17 (35.4%)
Secondary malignancy
9 (19.1%)
14 (29.2%)
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9. San Antonio Breast Cancer Symposium. December 6-10. 2016
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San Antonio Breast Cancer Symposium. December
First results at 3 year
Breast cancer recurrence, other tumor, death
Events
DFS
HR (CI)
Ibandronate 29
94.3%
0.80
( )
Control 46
90.8%
Bone metastasis
Events BM
HR (CI)
Ibandronate 8
1.6%
0.65
( )
Control 23
4.7%
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10. First results Safety and Toxicity
San Antonio Breast Cancer Symposium. December
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San Antonio Breast Cancer Symposium. December
First results Safety and Toxicity
More stomach / reflux related symptoms 2.2% vs 8.3%
20% stopped for side effects (not only ibandronate related)
4 patients (0.7%) developed osteonecrosis of the jaw
After treatment patients did not have complaints anymore
Renal function
Stable during ibandronate
5 patients (0.9%) stopped ibandronate
2 patients developed renal failure (possibly not related)
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11. Team Iib trial First conclusions & discussion
San Antonio Breast Cancer Symposium. December
BOOG
San Antonio Breast Cancer Symposium. December
Team Iib trial First conclusions & discussion
No proof of additional effect ibadronate at 3 years
However a trend towards
Improved disease free survival: 90.8%  94.3%
Less bone metastases: %  1.6%
Safe, but rare severe side-effect(s)
However
Is this analysis too early?
73 patients did not complete ibandronate treatment yet
Did we enroll enough women to show a difference?
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