Transcript First analysis of SWOG S0221: A phase III trial comparing

Combination Anastrozole and
Fulvestrant in Metastatic Breast
Cancer: Resurrection of Survival
Endpoint
Rita Mehta, MD
Associate Clinical Professor
Division of Hematology/Oncology
Department of Medicine
November 6th 2012
San Antonio Breast Cancer Symposium - Cancer Therapy and Research Center at UT Health Science Center – December 6-10,
2011
A phase III randomized trial of
anastrozole versus anastrozole and
fulvestrant as first-line therapy for
postmenopausal women with metastatic
breast cancer: SWOG S0226
Mehta RS, Barlow WE, Albain KS,
Vandenberg TA, Dakhil SR, Tirumali NR,
Lew DL, Hayes DF, Gralow JR,
Livingston RB, and Hortobagyi GN
This presentation is the intellectual property of the author/presenter. Contact them at [email protected] for permission to reprint and/or distribute.
Original Article
Combination Anastrozole and Fulvestrant in
Metastatic Breast Cancer
Rita S. Mehta, M.D., William E. Barlow, Ph.D., Kathy S. Albain, M.D., Ted A.
Vandenberg, M.D., Shaker R. Dakhil, M.D., Nagendra R. Tirumali, M.D., Danika L.
Lew, M.A., Daniel F. Hayes, M.D., Julie R. Gralow, M.D., Robert B. Livingston, M.D.,
and Gabriel N. Hortobagyi, M.D.
N Engl J Med
Volume 367(5):435-444
August 2, 2012
San Antonio Breast Cancer Symposium - Cancer Therapy and Research Center at UT Health Science Center – December 6-10, 2011
Epidemiology of breast cancer
Female/male ratio 100:1
 More than 200,000 women will be Dxd in US
 >40,000 will die of breast cancer
 2nd leading cause of cancer deaths in women

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Major
Determinants of treatment
Staging
 ER status-Negative and positive
 HER2 status-Negative and positive

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Staging
Stage 0 -- carcinoma in situ
 Stage I – tumor < 2 cm, no nodes
 Stage II – tumor 2 to 5 cm, +/- nodes
 Stage III – locally advanced disease,
fixed or matted lymph nodes and
variable tumor size
 Stage IV – distant metastases (bone,
liver, lung, brain)

Estrogen Receptor and
Antiestrogen
HER2 Over-Expression and
Trastuzumab in Breast
Cancer
San Antonio Breast Cancer Symposium - Cancer Therapy and Research Center at UT Health Science Center – December 6-10, 2011
Background

Of all women with breast cancer, 60% have tumors
that are positive for hormone receptors; this figure
rises to 75% for postmenopausal women with breast
cancer

Anastrozole lowers estrogen levels and fulvestrant
down-regulates the estrogen receptor

The combination of anastrozole and fulvestrant may
be additive in postmenopausal breast cancer
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Preclinical Data
Jelovac et al. Can Research 2005
Preclinical Data
Anastrozole + fulvestrant down-regulate signaling proteins:
Insulin-like growth factor type I receptor β, mitogen-activated protein
kinase (MAPK), p-MAPK, AKT, mammalian target of rapamycin
(mTOR), p-mTOR, and estrogen receptor α.
Macedo et al. Can Research 2008
San Antonio Breast Cancer Symposium - Cancer Therapy and Research Center at UT Health Science Center – December 6-10, 2011
S0226: Main Eligibility Criteria
• Postmenopausal women with metastatic breast cancer
(measurable or non-measurable)
• ER-positive or PgR-positive by local institutional standards
• No prior chemotherapy, hormonal therapy, or
immunotherapy for metastatic disease
• Prior adjuvant tamoxifen allowed (stratification factor)
• Prior adjuvant AI allowed if completed 12 months earlier
• Neoadjuvant or adjuvant chemotherapy completed more
than 12 months prior
• Patients were not allowed chemotherapy or other hormone
therapy while on treatment
• Must have given informed consent
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San Antonio Breast Cancer Symposium - Cancer Therapy and Research Center at UT Health Science Center – December 6-10, 2011
S0226: Schema
Arm 1
R
A
N
D
O
M
I
Z
E
Anastrozole only: 1 mg PO daily
Treat until progression; crossover to fulvestrant
strongly encouraged after progression
Arm 2
Anastrozole: 1 mg PO daily
First cycle of 28 days:
Fulvestrant 500mg IM ( 2 x 5 mL) Day 1
Fulvestrant 250mg IM ( 1 x 5 mL) Day 14
Fulvestrant 250mg IM ( 1 x 5 mL) Day 28
Subsequent cycles of 28 days:
Fulvestrant 250mg IM ( 1 x 5 mL) Day 28
Treat until progression
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San Antonio Breast Cancer Symposium - Cancer Therapy and Research Center at UT Health Science Center – December 6-10, 2011
S0226: Statistical Design
• Accrual goal: 690 eligible patients equally allocated and
stratified by use of adjuvant tamoxifen
• Primary endpoint: Progression-free survival (PFS)
– 90% power to detect an increase in median PFS from
10 months (monotherapy) to 13 months (combination)
with 2-sided α = 0.05 overall
• Planned analyses of the primary endpoint
– Two interim analyses at 50% and 75% of the events
– Final analysis at 2-sided α = 0.04
• Subset analyses were not planned and are not adjusted
for multiplicity
• Overall survival is a secondary endpoint
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San Antonio Breast Cancer Symposium - Cancer Therapy and Research Center at UT Health Science Center – December 6-10, 2011
Primary Comparisons
• Intent-to-treat analysis of eligible patients
• Analysis stratified by prior adjuvant tamoxifen
• Results as of December 2011:
– Population characteristics
• 707 patients randomized in the period
June 2004 to June 2009
• 694 analyzed excluding 12 ineligible patients
and one who withdrew consent
– Progression-free survival
– Overall survival
– Toxicity
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San Antonio Breast Cancer Symposium - Cancer Therapy and Research Center at UT Health Science Center – December 6-10, 2011
Crossover
• Patients in the anastrozole arm were strongly
encouraged to crossover to fulvestrant after
progression
• After Feb 15, 2011 patients on either arm could
crossover to 500 mg fulvestrant dosing after
progression
• 143 of 345 patients (41%) on anastrozole did
crossover to fulvestrant after progression
(including 5 who took the 500 mg dosing)
• 9 of 349 patients on the combination took
500 mg dosing after progression
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Baseline Characteristics of the Patients and the Disease, According to Treatment Group.
Mehta RS et al. N Engl J Med 2012;367:435-444.
Kaplan–Meier Curves for Progression-free Survival, According to Treatment Group.
Mehta RS et al. N Engl J Med 2012;367:435-444
Kaplan–Meier Curves for Overall Survival, According to Treatment Group.
Mehta RS et al. N Engl J Med 2012;367:435-444
San Antonio Breast Cancer Symposium - Cancer Therapy and Research Center at UT Health Science Center – December 6-10, 2011
Progression-Free Survival in S0226
1.00
No prior adjuvant tamoxifen (n=414)
0.75
Anastrozole + Fulvestrant (154 events)
Anastrozole (178 events)
Log-rank p = 0.0055
0.50
Median PFS
Anastrozole 12.6 mos (95% CI 11.2-15.6)
0.00
0.25
Combination 17.0 mos (95% CI 13.8-19.9)
HR = 0.74 (95% CI 0.59-0.92)
0
N at risk
AN 208
AN + FV 206
12
24
36
48
Months since registration
60
72
125
113
71
60
6
2
1
0
36
22
16
8
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San Antonio Breast Cancer Symposium - Cancer Therapy and Research Center at UT Health Science Center – December 6-10, 2011
Progression-Free Survival in S0226
1.00
Prior adjuvant tamoxifen (n=280)
0.75
Anastrozole + Fulvestrant (114 events)
Anastrozole (119 events)
Log-rank p = 0.37
0.50
Median PFS
Anastrozole 14.1 mos (95% CI 12.0-16.8)
0.25
Combination 13.5 mos (95% CI 11.0-19.3)
0.00
HR = 0.89 (95% CI 0.69 - 1.15)
0
N at risk
AN 141
AN + FV 139
12
24
36
48
Months since registration
60
72
74
80
43
32
2
1
1
0
17
17
5
3
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San Antonio Breast Cancer Symposium - Cancer Therapy and Research Center at UT Health Science Center – December 6-10, 2011
Overall Survival in S0226
1.00
No prior adjuvant tamoxifen (n=414)
0.50
0.75
Median OS
Anastrozole 39.7 mos (95% CI 33.1-43.9)
Combination 47.7 mos (95% CI 43.4-58.3)
0.25
HR = 0.74 (95% CI 0.56-0.98)
0.00
Anastrozole + Fulvestrant (91 deaths)
Anastrozole (108 deaths)
Log-rank p = 0.0362
0
N at risk
AN 208
AN + FV 206
12
24
36
48
Months since registration
60
72
190
181
158
139
13
12
1
2
91
77
34
30
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San Antonio Breast Cancer Symposium - Cancer Therapy and Research Center at UT Health Science Center – December 6-10, 2011
Overall Survival in S0226
1.00
Prior adjuvant tamoxifen (n=280)
0.50
0.75
Median OS
Anastrozole 44.5 mos (95% CI 38.0-54.8)
Combination 49.6 mos (95% CI 37.9-71.2)
0.25
HR = 0.91 (95% CI 0.65-1.28)
0.00
Anastrozole + Fulvestrant (63 deaths)
Anastrozole (68 deaths)
Log-rank p = 0.59
0
N at risk
AN 141
AN + FV 139
12
24
36
48
Months since registration
60
72
125
125
101
100
13
10
3
2
54
59
28
24
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San Antonio Breast Cancer Symposium - Cancer Therapy and Research Center at UT Health Science Center – December 6-10, 2011
Prior tamoxifen as a predictive factor?
• Overall planned analysis is highly significant
• Unplanned analysis by prior tamoxifen may suggest
benefit only in the tamoxifen naive group
• Prior tamoxifen use is confounded with time between
adjuvant diagnosis and metastatic diagnosis
• Need to better understand other possible predictive
factors since the prior tamoxifen factor could be a false
lead from an unplanned analysis
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Progression-free Survival, According to Subgroups.
Mehta RS et al. N Engl J Med 2012;367:435-444
San Antonio Breast Cancer Symposium - Cancer Therapy and Research Center at UT Health Science Center – December 6-10, 2011
S0226 Toxicity: Grade 4 and 5
•
•
•
Three patients on the combination had grade 5
toxicities:
–
two had pulmonary embolism
–
one had cerebrovascular ischemia
Two other patients on the combination had grade
4 toxicities:
–
one had pulmonary embolism
–
one had neutropenia and lymphopenia
Four patients on anastrozole alone had Grade 4
toxicities (thrombosis/embolism, arthralgia,
thrombocytopenia, dyspnea)
This presentation is the intellectual property of the author/presenter. Contact them at [email protected] for permission to reprint and/or distribute.
San Antonio Breast Cancer Symposium - Cancer Therapy and Research Center at UT Health Science Center – December 6-10, 2011
S0226 Toxicity
•
Grade 3 toxicities:
–
46 (13%) on the combination
–
38 (11%) on anastrozole alone
•
Includes musculo-skeletal pain, fatigue, hot
flashes, mood alterations and gastrointestinal
symptoms with frequency 1-4%
•
Adverse events did not differ significantly by
treatment group
•
Few patients went off treatment early due
to adverse events or side effects
(anastrozole alone 4; combination 11)
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San Antonio Breast Cancer Symposium - Cancer Therapy and Research Center at UT Health Science Center – December 6-10, 2011
First-Line Hormonal Agent Phase-III Studies
in Breast Cancer: Overall Survival
Study
N
OS: Control
Arm
(months)
OS:
Experimental
Arm (months)
HR for OS
P-value
S0226
NEJM 2012
707
Anastrozole
(→fulvestrant
(41.3)
Anastrozole +
Fulvestrant
(47.7)
0.81
0.049
Bergh SABCS
JCO 2012
514
Anastrozole
1.00
1.00
(38.2)
Anastrozole +
Fulvestrant
(37.8)
Nabholtz Eur
J C 2003
1021
Tamoxifen
(40.1)
Anastrozole
(39.2)
0.97
?
Mouridsen
JCO 2003
916
Tamoxifen
(30)
Letrozole
(34)
?
0.53
Paridaens
JCO 2008
371
Tamoxifen
(43.3)
Exemestane
(37.2)
1.04
0.82
Goss
JCO 2007
865
Letrozole
(34)
Toremifen +
Atamestane (36)
0.98
0.76
Howell
JCO 2004
587
Tamoxifen
(38.7)
Fulvestrant
(36.9)
1.29
0.04
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Table. Comparison of the S0226 and FACT trial.
Study
S0226 (n=707)
FACT (514)
Eligibility
HR+ metastatic breast cancer,
first-line; postmenopausal
Progression-free
survival
15.0 months vs. 13.5 months
favoring fulvestrant arm (HR,
0.80; P=0.0070)
10.8 months vs. 10.2 months ; no difference (HR,
0.99; P=0.91)
Overall survival
47.7 months vs. 41.3 months
favoring fulvestrant (HR, 0.81;
P=0.049)
37.8 months vs. 37.2 months; no difference (HR,
1.0; P=1.00).
Prior adjuvant
chemotherapy
33% (completion more than 12
months prior)
46% (timing not specified)
Cross-over to
fulvestrant
Strongly encouraged (41%
crossed over)
Not encouraged
Progression within 12
months of prior
tamoxifen
Low
Approximately 30%
Intent to Rx Analysis of
eligible patients
Patient characteristics balanced
Patient characteristics balanced?
Prior treatment
40% de-novo
All in first relapse
Prior tamoxifen
140/140 (280); 40% in
combination arm.
175 combination/164 mono-therapy (339); 70% in
combination arm.
HR+ breast cancer after first relapse (local or
metastatic); postmenopausal or premenopausal
Kaplan–Meier Estimates of Progression-free Survival, According to Whether Patients Were Randomly
Assigned to Receive Chemotherapy plus Trastuzumab or Chemotherapy Alone (Panel A), and Whether
Chemotherapy Consisted of Either a Combination of an Anthracycline and Cyclophosphamide (Panel B) or
Paclitaxel (Panel C).
Slamon DJ et al. N Engl J Med 2001;344:783-792.
Kaplan–Meier Estimates of Overall Survival, According to Whether Patients Were Randomly Assigned to
Receive Chemotherapy plus Trastuzumab or Chemotherapy Alone (Panel A) and Whether Chemotherapy
Consisted of Either a Combination of an Anthracycline and Cyclophosphamide (Panel B) or
Paclitaxel (Panel C).
HR=0.80
Slamon DJ et al. N Engl J Med 2001;344:783-792.
ECOG Trial, E2100: The Study
Overview
• This trial tested the effect of adding bevacizumab, a
monoclonal antibody against vascular endothelial growth
factor A, to the taxane paclitaxel for the initial treatment
of metastatic breast cancer
• As compared with paclitaxel alone, the combination
increased progression-free survival but not overall
survival
• The results are a demonstration of the potential benefit
of antiangiogenic treatment for breast cancer
Survival Analyses
HR: 0.60
Miller K et al. N Engl J Med 2007;357:2666-2676
HR: 0.88
CLEOPATRA: The Study Overview
•Pertuzumab, an anti-HER2 antibody, recognizes a
different epitope of HER2 than does trastuzumab and
behaves differently.
•In patients with metastatic breast cancer, the
combination of the two antibodies plus docetaxel
significantly increased progression-free survival.
CLEOPATRA: Progression-free Survival, as Assessed at an Independent Review Facility.
Baselga J et al. N Engl J Med 2012;366:109-119
Overall Survival.
Baselga J et al. N Engl J Med 2012;366:109-119
Which one of the following statements summarizes the results of S0226?
A. Combination therapy was associated with increase in progressionfree survival and the effect increased with time
B. Combination therapy was associated with increase in progressionfree survival and the effect decreased with time
C. Combination therapy was associated with shorter progression-free
survival
D. There was no difference between the groups with respect to
progression-free survival
THE STUDY OBJECTIVE, SHOWING A SIGNIFICANT IMPROVEMENT IN THE PRIMARY
END POINT OF PROGRESSION-FREE SURVIVAL WITH THE COMBINATION THERAPY,
WAS MET (P=0.007 WITH THE USE OF A TWO-SIDED STRATIFIED LOG-RANK TEST).
GENERALLY, THE SUPERIORITY OF THE COMBINATION THERAPY OVER
ANASTROZOLE ALONE WITH RESPECT TO PROGRESSION-FREE SURVIVAL EMERGED
OVER TIME: AT 1 YEAR, THE RATE OF PROGRESSION-FREE SURVIVAL WAS 57% WITH
COMBINATION THERAPY AND 56% WITH ANASTROZOLE ALONE; AT 2 YEARS, THE
CORRESPONDING RATES WERE 35% AND 28%, AND AT 3 YEARS, THE RATES WERE
25% AND 16%
Which one of the following conditions was the most common grade 3 toxic effect
observed in S0226?
A. Gastrointestinal disturbances
B. Hematologic effects
C. Musculoskeletal pain
D. Thrombosis
THE MOST COMMON GRADE 3 TOXIC EFFECTS WERE MUSCULOSKELETAL
PAIN (2.8%), INFLUENZA-LIKE SYMPTOMS (2.4%), GASTROINTESTINAL
DISTURBANCES (1.5%), AND HEMATOLOGIC EFFECTS (1.5%).
Which one of the following characteristics applies to the mechanism of action of
fulvestrant?
A. It is an aromatase inhibitor.
B. It is an estrogen Modulator (SERM).
C. It is an estrogen receptor down-regulator (SERD).
D. It is a gonadotropin-releasing hormone agonist.
FULVESTRANT (FASLODEX, ASTRAZENECA) IS AN ANALOGUE OF
ESTRADIOL THAT DOWN-REGULATES THE ESTROGEN RECEPTOR BY
DISRUPTING ESTROGEN-RECEPTOR DIMERIZATION AND ACCELERATING
DEGRADATION OF THE UNSTABLE FULVESTRANT–ESTROGEN-RECEPTOR
COMPLEX.2 THIS EFFECT LEADS TO REDUCED CROSS-TALK BETWEEN THE
ESTROGEN RECEPTOR AND ESTROGEN-INDEPENDENT GROWTH FACTOR
SIGNALING, THUS DELAYING RESISTANCE TO HORMONE THERAPY.
Conclusions
The combination of anastrozole and fulvestrant was superior to
anastrozole alone or sequential anastrozole and fulvestrant for the
treatment of HR-positive metastatic breast cancer, despite the use of a
dose of fulvestrant that was below the current standard.
The overall survival for combination was statistically superior than for
anastrozole alone, despite higher-than-projected survival for anastrozole alone.
The combination was not statistically associated with higher toxicity, despite
longer time on the combination.
Comparison of S0226 (and its subsets) to FACT suggests that benefit of
combination decreases with increasing endocrine resistance (acquired or
inherent).
How to Rx this patient?
• Age: 61 (A pt at Hoag)
• ER: 95%
• PR: 95%
• Tumor Type: IDC
• Tumor Size: 0.9 cm
• Tumor Grade: 2
• HER-2 Neg (FISH)
www.adjuvantonline.com.
How to Rx this patient?
Age: 35 ( a frequent
patient at UCI)
ER: neg/PR: neg
Tumor Type: IDC
Tumor Size: >5 cm
Tumor Grade: 3
HER-2 pos (FISH);
Chemo-sensitive vs
chemo-resistant
Neoadjuvant Chemotherapy +Trastuzumab
Neoadjuvant vs Adjuvant; Pathologic Complete Response in Neoadjuvant (in
vivo dynamic lab) vs Survival Endpoint in Adjuvant settings
A prem. female with
HER2-positive
relapsed IBC (2003)
Pre
Rx
Mid
Rx
Post
Rx
pCR
Pretest
probability near
0 in AC resistant
tumors, after 5/5
pathologic
response, post
test probability is
not Zero.
FDA will not
allow indication
based on
pathologic
complete
response; July
2004
Young adult with HER2-pos.
primary IBC (2003)
pCR
Annals of Oncology: Trastuzumab in inflammatory breast cancer; Mehta et al. 2008; Patient
is the teacher of clinician
Neoadjuvant options at UCI
•
2003-4:Pilot Study: AC followed by weekly paclitaxel, carboplatin + trastuzumab
(TCH)
– Sequential TCH reverses anthracycline resistance;
– high pathologic complete response will translate into high overall survival; ?
– short course of trastuzumab concurrent with optimized chemotherapy is
adequate Rx;
– minimum anthracycline may be important as it potentially targets cells with
topoisomerase-II co-amplified cells in a heterogeneous HER2 population
(SWOG, SABCS 2004)
•
2004-5: UCI03-70: AC followed by weekly paclitaxel, carboplatin +/- trastuzumab
(n=48)
- Pathologic complete response following TCH does translate into superior overall
survival (SABCS 2008)
•
2005-7:UCI 05-38: AC followed by Albumin-paclitaxel, carboplatin +/trastuzumab or bevacizumab (n=43)
– Pathologic complete response following dose-dense metronomic
chemotherapy translates into high overall survival for triple negative breast
cancer (JCO 2008)
•
2008-2013: UCI07-61 : Albumin-paclitaxel, carboplatin +/- trastuzumab or
bevacizumab (n=100+/120); DD AC is optional
Trastuzumab-based combinations
•
•
•
•
Studies 1 & 2: [NSABP 31 (UCI) and NCCTG] NEJM Oct 2005
After completion of AC, Herceptin weekly taken with Taxol weeks 1-12 followed by Herceptin alone weekly
•
•
•
•
Study 3: HERA NEJM Oct 2005
After surgery and chemotherapy, Herceptin taken every 3 weeks
•
•
Study 4: Slamon et al. NEJM 2012
After completion of AC, Herceptin weekly taken with Taxotere weeks 1-12 followed by Herceptin alone
every 3 weeks
•
•
52% higher chance of remaining cancer free longer in the group of women who received AC→TH*
(n=1872) compared with the group that received AC→T (n=1880)
46% higher chance of remaining cancer free longer in the group of women who received Herceptin alone†
(n=1693) compared with the group that did not receive Herceptin (n=1693)
40% higher chance of remaining cancer free longer in the group of women who received AC→TH*
(n=1074) compared with the group that received AC→T (n=1073)
•
Study 4:
•
After surgery, Herceptin weekly taken with Taxotere and carboplatin weeks 1-18 followed by Herceptin
alone every 3 weeks
•
•
33% higher chance of remaining cancer free longer in the group of women who received TCH† (n=1075)
compared with the group that received AC→T (n=1073)
Trial Design: Neoadjuvant vs Adjuvant
in Triple Negative Breast Cancer
• Each 10% increase in pathologic complete response
will translate into an absolute 2.6% 3-year survivalTN breast cancer specific calculation
• Combination cytotoxic chemotherapy administered
in a dose-dense or metronomic schedule remains
the standard therapy for early-stage TNBC.[2011 NCI
PDQ*]
•
•
Dose-dense and/or metronomic schedules of specific chemotherapies
consolidate the chemosensitivity of triple-negative breast cancer: a step toward
reversing triple-negative paradox
*Mehta RS:. J Clin Oncol 26 (19):, 2008
FDA will allow pathologic
complete response rate
endpoint for accelerated
approval of new drugs 2012.
Immediate Goal is to find the
driver mutation and treat.
Courtesy:
Albain
Breast Center Team & Collaborators
• Campus: Drs. Tromberg, Su, Chen, Nelson (MRI and Laser Optics)
• Breast Center: Drs. Butler, Lane and Hsiang
• Hematology/Oncology: Drs. Sender, Nelson, Fruehauf, Zell, Nangia, Seery,
Fellows
• Cancer Center
• Radiologists; Drs. Feig and Campbell
• Members of IRB/CTPRMC/CRO/CRAC
• Nurses
• Patients
Thank You