Essentials of ALTTO

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Essentials of ALTTO

• Frances M Palmieri, RN, MSN, OCN, CCRP
• Nursing Liaison

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Essentials of ALTTO

• What is ALTTO
• Worldwide Collaboration
• Enrollment Update
• Rationale for Study Design
• Mechanism of action of anti-HER2 agents
• Scientific rationale for inclusion of lapatinib
• NCCTG Study Team
• Overview of Treatment/ Adverse Events
• Management of Treatment Effects
• Challenges Recruitment and Enrollment

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Essentials of ALTTO
N063D/BIG2-06/EGF106708
A randomised, multi-centre, open-label, phase III
study of adjuvant lapatinib, trastuzumab, their
sequence and their combination in patients with
HER2/ErbB2 positive primary breast cancer
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(No Transcript)
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ALTTO World Tour An International Collaboration

• Two Study Co-Chairs
• Edith A Perez MD NCCTG USA The Breast Cancer
  Intergroup (NCIC), and CTSU
• Coming soon US Oncology
• Martine Piccart MD Breast International Group
  (B.I.G.) Belgium

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ALTTO World Tour An International Collaboration

• Statistical Center
• Frontier Science USA and Scotland
• Data Center
• Breast European Adjuvant Study Team (BrEAST) -
  Belgium

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ALTTO Group Participation
GBG GBOC GECO PERU GOCCHI GOIRC IBCSG/SAKK/EIO ICC
G ICORG JBCRG

• ACCOG
• ANZ BCTG
• AGO-NEO
• BOOG
• BrEAST
• DBCG
• EORTC
• GBECAM

NBCG NCRI SBCG SOLTI TCOG WSG YBCRG
Rest of the world BIG
North America TBCI
NCCTG, ECOG, SWOG, CALGB, NCIC
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ALTTO A Model of Partnership

• BIG/BrEAST
• Contracts/budgets
• Set up committees
• Hosting/admin. of
• unique database
• Study management
• Medical Revision
• Translational research
• NCCTG
• Contracts/budgets
• Coordination of North American centers
• Contact with NCI-FDA
• Translational research
• QOL
• FSS
• Randomization
• Data management

Pharmaceutical Industry

• Shared Tasks
• Protocol design, writing
• CRF design
• Database set up
• Daily trial management
• Monitoring
• Programming of statistical
• analyses for registration
• Organization of investigator
• monitor workshops
• Coordination of steering
• committee meetings

• Sponsor
• Study Drug
• CRF shipment
• SAE reporting to
• authorities

NCI
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DESIGN 1 Intention to Complete all (neo)Adjuvant
Chemotherapy Prior to Targeted Therapy
X
Locally-determined HER2-positive invasive breast
cancer (For patients with neoadjuvant treatment,
the HER2 determination should be done on a tissue
sample taken before the treatment is started)
Centrally-determined HER2, ER, PR
Surgery, complete (neo)adjuvant
anthracycline-based chemotherapy (selected from
an approved list)
LVEF ? 50
Lapatinib 1500 mg for 52 weeks
Weekly Trastuzumab (12 weeks)
Lapatinib 1000 mg 3-weekly Trastuzumab for 52
weeks
3-weekly Trastuzumab for 52 weeks
Washout (6 weeks)
Lapatinib 1500 mg (34 weeks)

• Patients with ER or PgR-positive tumors receive
  endocrine therapy selected accordingly to
  menopausal status endocrine therapy will be
  started after the end of chemotherapy, will be
  administered concurrently with targeted therapies
  and will be planned for at least 5 years
• Radiotherapy if indicated

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Essentials of ALTTO Study Design Design 2
Schema
Trastuzumab 1
Taxane
Lapatinib 2
Surgery ChemoComplete
Taxane
Randomize
Wash out
Lapatinib 3
Trastuzumab
Taxane
Consent Send Blocks for Central Path Review
34 Weeks
6 Weeks
12 Weeks
Lapatinib Trastuzumab 4
Taxane
52 Weeks
All Patients Radiotherapy, if indicated Hormone
receptor-positive patients Endocrine therapy
for at least 5 yrs
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ALTTO Key Inclusion Criteria (I)

• Age 18 years (male or female)
• Early breast cancer (non-metastatic)
• Node negative (tumor size 1.0 cm) or node
  positive
• Central HER2 defined as
• 3 by IHC (gt 30 of invasive tumor cells) or
• FISH ratio gt 2.2 (ASCO/CAP guideline)
• ALTTO Central Lab Milan (ex-North America), and
  Mayo (North America)
• Estrogen and Progesterone receptors centrally
  tested before randomization (strata)
• LVEF 50 (ECHO or MUGA) after completion of
  anthracycline-based CT

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ALTTO Key Inclusion Criteria (II)

• Must have received at least four cycles of an
  approved anthracycline-based CT
• Taxanes may be given PRIOR to randomization
  (paclitaxel or docetaxel) (design 1)
• Design most commonly used outside US
• If intention to administer a taxane CONCURRENTLY
  with targeted therapy, PACLITAXEL is allowed
  (design 2)
• Design most likely to be used in the US
• Docetaxel concomitant with targeted therapy
  (i.e., TCH) is now allowed

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Acceptable Chemo Regimens

• MAIN RULE Minimum of 4 cycles of
  Anthracycline-based chemotherapy required (in the
  case that only 4 cycles of (neo)- adjuvant
  chemotherapy are to be given, each cycle must
  contain an anthracycline at an acceptable dose)
• Taxanes, either P or D at any dose, can be after
  the 4 cycles of anthracycline-based chemotherapy
• For all regimens, the maximum cumulative
  allowable dose of doxorubicin (A) is 360mg/m2 and
  of epirubicin (E) is 720mg/m2
• TCH not yet allowed in ALTTO, but safety data
  accumulating

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ALTTO Statistical Analyses

• Primary Endpoint Disease-free survival (DFS)
• Secondary Endpoints
• Adverse events, cardiac events, incidence of
  brain metastases
• TTR, TTDR, OS
• Separate analyses according to c-Myc
  amplification, PTEN amplification levels,
  presence of p95HER2 domain
• Subgroup Analyses
• ER/PgR, menopausal status or age, nodal status,
  chemotherapy type

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ALTTO Statistical Analyses (II)

• Intent to treat (ITT) analysis
• 80 power to detect DFS HR 0.78
• 8000 patients needed
• 1386 DFS events needed
• Planned Analyses
• Two interim analyses at 600 (3.8 yrs) and 1000
  (4.6 yrs) DFS events
• If any experimental arm is significantly worse
  than the control group, d/c recommended
• Final analysis at 1386 DFS events, expected at
  5.5 yrs

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ALTTO Translational Research State of the Art
Technologies
Genomics
Circulating Tumor Cells
Proteomics/Metabolomics
Genetics
Tissue, blood specimens
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ALTTO Translational Research (I)

• All Cases
• Central pathology review
• HER2 tested using both ICH and FISH
• ER and PgR centrally tested
• TMA construction using FFPE tumor blocks
• Topoisomerase II alpha (FISH)
• PTEN (IHC), c-Myc (FISH), and p95HER-2
• Tests under discussion ErbB1, ErbB3, ErbB4,
  pErbB1, pErbB2, AKt, pAKT, S6, pS6, MAPK, pMAPK
  IGFR1, Ki-67, P27, and Cyclin D1

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ALTTO Translational Research (II)

• TMA construction
• Blood samples for GSK to do PGx (with specific
  consent)

for all women
Tumor Biobank
n 8000
Additional Studies

• Circulating tumor cells (CTSU and Rest of World)
• Serum proteomics (Rest of World)
• Frozen tumor for gene expression profiling (Rest
  of World)
• Blood specimen banking at serial timepoints
  (CTSU)

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Patient Enrollment
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Enrollment UpdateCurrent Global Enrollment
US Enrollment
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Enrollment UpdateNorth American Enrollment By
Group
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Current Adjuvant Anti-HER2 Rx
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Reported Adjuvant Trastuzumab Trials
R ANDOMIZE
Chemotherapy No trastuzumab
Women with HER2 3 (IHC) or FISH breast
cancer Confirmed by central lab or approved by
ref. lab
N13,365
Chemotherapy and trastuzumab

• Type of chemotherapy
• Timing of T initiation
• Schedule of T administration
• Duration of T administration

Variables in the 5 trials
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Results from Adjuvant Trastuzumab Trials
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Rationale for Lapatinib
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80-85 of Women are Disease Free at 4 yrs with
Trastuzumab
15-20 are Not
CAN WE IMPROVE UPON THESE RESULTS?
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Lapatinib is the First Oral, Small Molecule,
Dual Targeted Agent that Binds Intracellularly
Bevacizumab
Ertumaxomab
VEGF
Pertuzumab
Trastuzumab
ErbB2
ErbB3
IGF-IR
VEGFR
ErbB2
PDGFR
ErbB1
Pazopanib
Sunitinib
Lapatinib
Tanespimycin Alvespimycin
Vorinostat
Temsirolimus Everolimus
HDAChistone deacetylase
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Lapatinib Acts Intracellularly, Directly
Inhibiting Downstream Signals
TYB033/10/08 Nov 2008
Ligands
ErbB2
Other ErbB
Lapatinib
Proliferation
Cell cycle, Survival
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Lapatinib in HER2 Breast Cancer Lines
Trastuzumab-Conditioned BT474 Cells
100
90
trastuzumab

• Lapatinib inhibits growth of breast cancer cell
  lines that acquire resistance to a
  therapeutically relevant dose of trastuzumab
• Lapatinib in combination with trastuzumab is
  synergistic in HER2 breast cancer cell lines

80
70
60
Fraction unaffected ()
50
40
lapatinib
30
20
10
0
Nmol lapatinib
500
250
125
62
39
15
7
3
1.5
Nmol trastuzumab
13
0.05
MDA-MB-361 Cells
Konecny, et al. Cancer Res 2006 661630-39
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Proposed Mechanisms of Resistance to Trastuzumab
p95HER2 truncated form
HER1HER3 signaling
Lateral signaling
Nahta, et al. Nat Clin Pract 2006 3(5)269-80
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Trastuzumab Resistance ECD/ p95HER2

• p95HER2 is a truncated HER2 receptor that lacks
  the external domain (binding site for trastuzumab
• Truncated receptor demonstrates increased kinase
  activity and transforming potential
• Approximately 25 of HER2 breast cancers express
  p95HER2,
• 9 of breast cancers high levels of p95HER2 - it
  predicts worse outcome

Trastuzumab
185kd
serum
95kD
Trastuzumab binds to extracellular domain and
cannot inhibit free p95HER2
Saez, et al. Clin Can Res 2006 12424-31
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Lapatinib Inhibits p95HER2 Phosphorylation
vehicle lapatinib trastuzumab
pp185ErbB2 pp95ErbB2
WB a phospho-ErbB2 (Y1248)

• Lapatinib may inhibit growth of tumors that
  highly express p95HER2
• An assay in paraffin is available in addition to
  western or frozen tissue testing
• Testing of p95HER2 in tumor samples from patients
  treated with lapatinib to confirm the preclinical
  data is underway
• May be most important for patients refractory to
  trastuzumab

The clinical relevance of this finding is unknown
Xia, et al. Oncogene 2004 23646-53
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Lapatinib in Patients with Refractory Breast
Cancer
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EGF100151 Phase III, Open-label, Multi-center
study
Randomized Study in Relapsed Patients with HER2
Breast Cancer

• Key Inclusion
• Incurable Stage III/IV BC
• Prior treatment with anthracyclines, taxanes and
  trastuzumab
• HER2 positive

RANDOMIZATION
Capecitabine 2000 mg/m2 QD Lapatinib 1250 mg po QD

• Stratification
• Disease site
• Disease stage (III/IV)

Capecitabine 2500 mg/m2 QD
N 399
Primary Endpoint Time to Progression
Cameron, et al. BCRT 2008 112(3)533-43
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EGF100151 Time to Progression in ITT
Cumulative Progression-Free ,
100
Lapatinib Capecitabine
Capecitabine
90
201
198
ITT No. of pts
80
102 (51)
82 (41)
Progressed or died
18.6
27.1
Median TTP, wk
70
0.57 (0.43, 0.77)
Hazard ratio (95 CI)
60
P-value (log-rank, 1-sided)
0.00013
50
40
30
20
10
0
0
10
20
30
70
40
50
60
Time (weeks)
Cameron, et al. BCRT 2008 112(3)533-43
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EGF104900 (Refractory) Study Design
RANDOMIZATION

• Key Inclusion
• HER2(FISH/ IHC3) MBC
• Progression on
• Anthracycline
• Taxane
• Trastuzumab
• Progression on most recent trastuzumab regimen

Lapatinib 1500 mg/day PO N148
Crossover if PD after 4wk therapy (N73)
Lapatinib 1000 mg/day PO Trastuzumab 4 2
mg/kg IV qw N148

• Stratification Factors
• Visceral Disease
• Hormone Receptor

Primary Endpoint PFS
OShaugnessy, et al. ASCO 2008
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EGF104900 Treatment Efficacy
Confirmed CRPR
CRPRSD 6 mo
OShaugnessy, et al. ASCO 2008
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Lapatinib in Patients with CNS Metastasis
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Breast Cancer Brain Metastasis

• Background
• Approximately 35 of HER2 breast cancer patients
  develop CNS metastases
• Increase in CNS as first site of relapse in
  adjuvant trials of trastuzumab
• In vitro, lapatinib inhibited the phosphorylation
  of EGFR, HER2, and downstream signaling proteins
  cell proliferation and migration in
  brain-seeking breast cancer cells (both with and
  without HER2 overexpression)

Ono, et al. Int J Clin Oncol 2009 1448-52
Romond, et. al , NEJM 2005 3531673-84 Gril,
et al. JNCI 2008 100(15)1092-103
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Lapatinib for Brain Metastases In vivo evidence
Mouse brain

EGFP labeled 321BR-HER2 (1.75 x 105 cells)

• Lapatinib, at 30-100 mg/kg,
• prevented the outgrowth of HER2 brain
  metastases by 50.
• These data suggest that lapatinib may prevent
  brain relapse in adjuvant clinical trials.
• A complex set of signaling pathways is altered
  by lapatinib in vitro.

Control
Lapatinib 100 mg/kg (days 5 - 21)
Gril, et al. JNCI 2008 100(15)1092-103
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EGF105084 Lapatinib MonotherapyN242
CNS composite objective response requiring no
new or progressive non-CNS lesions, increase in
steroid requirements or increase in neurological
signs or symptoms. Exploratory analysis.
Lin, et al. SABCS 2007
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Incidence of Brain Metastases as Site of 1st
Relapse in Capecitabine /- Lapatinib (study
EGF100151)

Cameron, et al. BCRT 2008 112(3)533-43
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ALTTO Study Updates
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Summary of Revisions to ALTTO Study Design

• Amendment 03 Issued on 13-February-2009 to
  clarify the need for balance between the 2 study
  designs
• Timing of taxane chemotherapy (Design 1 vs.
  Design 2) is a stratification variable. Closing
  of Design 1 required to allow for statistically
  meaningful analysis of outcome for Design 2
• Amendment 04
• Allow for use of docetaxel as a concurrent
  chemotherapy (Design 2)
• Inclusion of additional planned interim
  analysis at 400, 700 and 1000 DFS events
• Final analysis to occur after 1388 DFS events
• Future Amendment allow for docetaxel in
  combination with carboplatin in Design 2
• Following completion of NCCTG phase II safety
  study of docetaxel and carboplatin in combination
  with trastuzumab and lapatinib (N083E)

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Overview of Treatment Effects
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Expected Therapies

• Taxanes
• Paclitaxel (Taxol)
• Docetaxel (Taxotere)
• Trastuzumab (Herceptin)
• FDA approved for MBC September 1998 and for EBC
  in November 2006
• Lapatinib (Tykerb)
• FDA approved for MBC March 2007
• TCHL (docetaxel-carboplatin) regimen
• Safety data in collection now

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Potential Adverse Events
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Lapatinib GI Effects

• Diarrhea
• Take 1 hour before or after food intake
• Combination with food ? risk
• Assess/grade severity
• Soft frequent stool vs. watery diarrhea
• Pharmacological intervention with ? stool
  frequency, watery stools or discomfort (cramping)
  
• Loperamide (Imodium), Diphenoxylate w/atropine
  (Lomotil)
• Dietary modifications

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Lapatinib GI Effects

• Nausea/vomiting
• Infrequent, manage conservatively
• Dietary changes prochlorperazine usually
  sufficient
• May need 5-HT3 inhibitor if refractory to
  prochlorperazine (occasional)
• Stomatitis/mucositis
• Generally mild, Grade 1-2, resolves in 5-6 days

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Diarrhea Management
Re-evaluate weekly for 2 weeks
G 2
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Lapatinib Dermatologic Effects

• Rash
• Characteristic pustular/papular appearance
• Face, head, scalp, upper torso with pruritus, dry
  skin, erythema common
• Secondary infections
• Yellow exudate, crusty surface
• Pustules, warmth, pain
• Tetracycline or clindamycin recommended
• See NCCN Rash Guidelines 2009

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Rash Assessment Management

• Rash Management
• Moisturizer/emollients to alleviate dryness
• Use makeup
• Remove makeup with mild liquid cleanser - Dove,
  Neutrogena, Ivory Skin Cleansing Liqui-Gel
• Use sunscreen (SPF 30)

Images courtesy of Susan Moore
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Other Lapatinib Issues

• Congestive Heart Failure (CHF)
• Incidence of 3 in N9831 (trastuzumab)
• Low cardiotoxic potential seen in 3689 patients
• Any cardiac event 1.6, symptomatic in 0.2
• Follow stringent cardiac monitoring and reporting
• Drug Administration
• Avoid concomitant strong CYP3A4 inhibitors
  including grapefruit /juice
• POM, Acai
• All tabs are taken as one dose each day

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Cardiac Function in Patients Receiving Lapatinib

• Evaluated
• 3689 patients treated with lapatinib in 44 phase
  I-III clinical trials in breast cancer and other
  malignancies
• Methods
• LVEF monitored with ECHO/MUGA q8 wks
• Cardiac Risks Collected
• Age, prior known cardiac disease, previous
  exposure to mediastinal / left-sided RT
• Data Collected for LVEF if
• gt grade 3 toxicity
• gt 20 decline relative to baseline and below
  institutions lower limit of normal

Perez, et al. Mayo Clin Proc 2008 83(6) 679-86
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Cardiac Safety Profile of Lapatinib
Data of 3689 Patients
Cardiac event defined as symptomatic ( NCI
CTCAE v3, Grade 3 or 4 systolic dysfunction) or
asymptomatic (LVEF decrease 20 relative to
baseline and below the institutions lower limit
of normal no symptoms)



Perez, et al. Mayo Clin Proc 2008 83(6) 679-86
.
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Cardiac Safety Profile of Lapatinib Data
Summary of 3689 Patients

• 1.6 (60/3689) patients experienced cardiac event
• Only 0.2 (7/3689) patients were symptomatic
• In the 274 patients who received lapatinib for at
  least 6 months, no cumulative or dose related
  toxicity was observed
• No cardiac death attributed to lapatinib
• Overall
• Rarely symptomatic and generally reversible
• Incidence lower than the incidence of
  asymptomatic LVEF decreases observed in the
  general population or those treated in
  trastuzumab studies

Perez, et al. Mayo Clin Proc 2008 83(6) 679-86
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Treatment Related Fatigue

• Reported as one of the most problematic side
  effects related to many therapies, and the
  disease itself
• Diminishing quality of life/ability to manage
  self-care
• Symptoms may include
• Lethargy weakness or total lack of energy,
  malaise
• Sleeplessness
• Anxiety
• Difficulty with concentration, thinking clearly,
  making decisions

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Treatment Related Fatigue

• Interventions that help alleviate fatigue
• Regular exercise (Evidence Based)
• Correct known causes of fatigue
• Anemia, nutritional deficits, sleep disorders
• Anti-depressant and anti-anxiety medications
• Other lifestyle modifications
• Attention-restoring activities
• Psychological counseling, physical therapy
• Medications to relieve pain experienced with
  myalgia/arthralgia

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Self Care Thoughts

• Timely reporting is essential
• Adverse events should be manageable
• Utilize your Oncology Team to help determine
  reportable issues
• Accurate diarrhea reporting
• Dose modification and treatment interruption
  should be made per protocol
• Always use good medical judgment but
  communicate with study team
• Utilize supportive care strategies
• Carefully discuss long term adherence issues

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Ongoing Challenges
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Pre-Registering a PatientSubmitting Pathology
Samples for Review
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Reimbursement Available Remember to Send in Your
Form to NCCTG

• Reimbursement available
• Reimbursement payments of up to 11,997 US per
  patient (divided into four payment time points).
• The first reimbursement can be requested as soon
  as a patient is randomized and the Screening CRF
  is submitted.

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Where do I find the Form? Remember to Send in
Your Form to NCCTG
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Paperwork and SpecimensWhere does all this stuff
go?

• Fax to CTSU
• Requests for Central Pathology ID
• Requests for randomization
• Send to NCCTG
• Tissue Blood specimens with corresponding
  paperwork
• QOL Booklets
• All related forms listed in Appendix 6 - North
  American Procedures
• Fax to BrEAST (CliniFax)
• ALTTO Case Report Forms
• Send to AdEERS
• All SAEs as usual

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The ALTTO Study TeamWere Here to Answer Your
Questions!

• Did you know that theres a toll-free Patient
  Information Hotline (just for patients)?
• Phone [phone]

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The ALTTO Study TeamWere Here to Answer Your
Questions!

• Any Questions About ALTTO
• Send an email to altto_at_mayo.edu
• Central Pathology Review Submission
• Tabitha K Hanson
• Phone [phone]
• email hanson.tabitha_at_mayo.edu
• Patient Eligibility Treatment
• Barb Mulhern
• Phone [phone]
• email mulhern.barbara_at_mayo.edu

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The ALTTO Study TeamWere Here to Answer Your
Questions!

• Study Related Documents
• Lynn Flickinger
• Phone [phone]
• email flickinger.lynn_at_mayo.edu
• Kristen Perkins
• Phone [phone]
• email perkins.kristen_at_mayo.edu
• Adverse Event Submission
• Pat McNamara
• Phone [phone]
• email mcnamara.patricia_at_mayo.edu

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ALTTO Recruitment Barrier Identification and
Proposed Strategic Interventions

• NCCTG Breast Committee ALTTO Team
• Collaborative effort with the NCI, BIG, Frontier
  Science, Glaxo

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ALTTO Recruitment Materials Tactics

• Educational Toolkit
• 1. Patient brochure
• 2. ALTTO Trial Presentation to Patients flip
  chart
• 3. Live QA Archived webcast, Lapatinib
• 4. DVD of webcast
• 5. ALTTO Quick Reference Note Cards
• 6. Diarrhea Guidelines Chart
• 7. Stepwise Central Pathology Review Chart
• 8. Monthly ALTTO Voice newsletter
• 9. Mini-Protocol handbook
• 10. NCCTG Reminder Tools Magnet, paper sticky
  pads, Appendix 6 bookmark with ALTTO
  contact phone numbers and web contact
• 11. Sample ALTTO trial Ad
• 12. List of Patient Resources Advocate
  organization links, Patient Information
  Hotline [phone])
• 13. Order link/form for toolkit

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Helpful Items AvailableOrder from CTSU
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ALTTO Recruitment MaterialsTactics (continued)

• Bi-monthly newsletter
• Available in Toolkit, CTSU website, and
  disseminated to each cooperative group operations
  recruitment liaison
• Survey sites
• To query trial activation/enrollment
• Create map and a list that details each
  participating site by co-op group
• Individual or regional meetings to network with
  individual sites
• Regional dinner symposium or in-office
  presentations

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ALTTO Recruitment MaterialsTactics (continued)

• Monthly meeting with ALTTO NCCTG team with
  co-operative group representatives (one assigned
  operations person from each group) that will
  focus on recruitment
• Monthly meetings with Dr. Perez and other
  cooperative group chairs with agenda specific to
  recruitment
• PowerPoint adverse event management presentation
• Attend each Co-operative group meeting
• Informational table with toolkit items
• Podium ALTTO presentation

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ALTTO Recruitment MaterialsAdvocacy

• Advocate Toolkit
• 1. Patient education materials
• One-page patient language trial summary,
  brochure, rationale for lapatinib alone arm, fact
  sheets addressing key patient concerns such as
  trial availability, patient information phone
  line, management of side effects, insurance
  issues
• 2. ALTTO Talking Points Bullet points about the
  ALTTO trial for advocacy group staff who answer
  advocate hotlines
• 3. ALTTO Brief Description
• Sample abbreviated description of ALTTO to
  include in advocate group newsletter/website with
  patient information phone line contact number
• 4. Advocate National Meeting Presence

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ALTTO Recruitment Materials Advocacy

• Advocacy Webcasts/Teleconferences
• Advocate National Meeting ALTTO Presence
• Informational table staffed by ALTTO Team
• ALTTO Advocate Toolkit materials at all major
  breast cancer advocacy meetings
• Adjunct ALTTO Advocate Forum/Symposium
• In conjunction with large breast cancer meetings

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Questions