Jointly provided by Postgraduate Institute for

Medicine and Clinical Care Options, LLC

HER2-Negative Metastatic Breast

Cancer: Chemotherapy After
Anthracyclines and Taxane Treatment
Joyce OShaughnessy, MD
Director, Breast Cancer Research Program
Baylor Charles A. Sammons Cancer Center
Texas Oncology
US Oncology
Dallas, Texas

This activity is supported by an educational grant from Eisai.

Chemotherapy After Anthracyclines and Taxane Treatment

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Single vs Combination Regimens

No compelling evidence that combination regimens are superior to sequential singleagent regimens or that cytotoxic agents are subtype specific

Single Agent

Combination

Anthracyclines

CAF/FAC (cyclophosphamide/
doxorubicin/fluorouracil)

Doxorubicin, pegylated
liposomal doxorubicin
Taxanes
Paclitaxel
Antimetabolites
Capecitabine, gemcitabine
Nontaxane microtubule agents
Vinorelbine, eribulin, ixibepilone

FEC (fluorouracil/epirubicin/cyclophosphamide)
AC (doxorubicin/cyclophosphamide)
EC (epirubicin/cyclophosphamide)
CMF
(cyclophosphamide/methotrexate/fluorouracil)
GT (gemcitabine/paclitaxel)
Docetaxel/capecitabine
Gemcitabine/carboplatin
Paclitaxel/bevacizumab

1. NCCN. Clinical practice guidelines in oncology: breast cancer. v.1.2015.

Chemotherapy After Anthracyclines and Taxane Treatment

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TNBC vs Other Phenotypes in the

California Cancer Registry Study

Population-based study
6370 (12%) with triple-negative disease compared with 44,704 other cases

TNBC more likely to be associated with

Younger age (< 40 yrs) (OR: 1.53)
Non-Hispanic black (OR: 1.77) or Hispanic (OR: 1.23)
Higher grade (72% grade 3)
More advanced stage (66% stage II vs 50% ER positive/HER2 negative)
Poorer 5-yr RFI regardless of stage
TNBC: 76% (similar to 76% for HER2+)
Hormone receptor positive, HER2 negative: 94%

Greater propensity for lung and brain metastases

2. Bauer KR, et al. Cancer. 2007;109:1721-1728. 3. Parise CA, et al. Breast J. 2009;15:593-602.

Chemotherapy After Anthracyclines and Taxane Treatment

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TNT: Carboplatin vs Docetaxel in

Advanced TNBC or BRCA1/2+ BC
Patients with ER-,
PgR-/unknown, and
HER2- or BRCA1/2+
metastatic or
recurrent LA BC
(N = 376)

Carboplatin AUC6 q3w

x 6 cycles (n = 188)
Docetaxel 100 mg/m2 q3w
x 6 cycles ( n = 188)

For both arms,

crossover upon
progression allowed

Primary endpoint: ORR in ITT population

Secondary endpoints: PFS, OS, ORR (crossover), toxicity
Subgroup analyses: BRCA1/2 mutation, basal-like subgroups,
HRD biomarkers
4. Tutt A, et al. SABCS 2014. Abstract S3-01.

Chemotherapy After Anthracyclines and Taxane Treatment

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TNT: Carboplatin vs Docetaxel in

Advanced TNBC or BRCA1/2+ BC: ORR
Response at Cycle 3 or 6 (%)

90

Carboplatin
Docetaxel
Crossover

80
70

P = .03
68.0%

60
50
40
30

P = .44
35.6%
31.4%

P = .73
22.8% 25.6%

33.3%

P = .16
36.6%
28.1%

20
10
0

All Pts
(N = 376)

CDC
Crossover*
(All pts; n = 182)

BRCA1/2
Mutation
(n = 43)

*Excludes those with no first progression or not starting crossover treatment.

4. Tutt A, et al. SABCS 2014. Abstract S3-01.

No BRCA1/2
Mutation
(n = 273)

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PFS (%)

TNT: Carboplatin vs Docetaxel in

Advanced TNBC or BRCA1/2+ BC: PFS

100
90
80
70
60
50
40
30
20
10
0

Median PFS, Mos (95% CI)

Carboplatin: 3.1 (2.5-4.2)
Docetaxel: 4.5 (4.1-5.2)

6
9
12
Mos From Randomization

Median OS was similar with carboplatin and docetaxel (12.4 vs 12.3 mos)

4. Tutt A, et al. SABCS 2014. Abstract S3-01.

15

18

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TNT: Carboplatin vs Docetaxel in Adv

TNBC or BRCA1/2+ BC: PFS by BRCA1/2
100

Carboplatin + BRCA1/2 mutated

Carboplatin + BRCA1/2 not mutated
Docetaxel + BRCA1/2 mutated
Docetaxel + BRCA1/2 not mutated

90
80

PFS (%)

70
60
50
40
30
20
10
0

3
6
9 12 15 18
Mos From Randomization

4. Tutt A, et al. SABCS 2014. Abstract S3-01.

Median PFS, Mos

Carbo

Doc

BRCA1/2 mutated

6.8

4.8

BRCA1/2 not
mutated

3.1

4.6

Chemotherapy After Anthracyclines and Taxane Treatment

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Case Study: Novel Therapy for Metastatic

TNBC
28-yr-old Hispanic woman, 4 yrs postpartum, with left breast
T3N0 grade 3 TNBC (ER, PgR, HER2 negative), ki67 80%,
high grade carcinoma with sarcomatoid features
BRCA1/2 wild type
Preop DD AC with PgR, then preop weekly paclitaxel plus 4
cycles carboplatin AUC 6 with minor response
Bilateral mastectomy: 3.6-cm residual disease with metaplastic
features, N0, no LVI, ki67 75-100%, ER, PgR HER2 0
Received PMRT
Menses resumed

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Case Study (contd)

5 mos after radiation, developed RUQ pain with a 7 x 6 cm
solitary liver metastasis
Liver biopsy: highly mitotic, ER, PgR, HER2-negative
carcinoma
NGS of residual disease post-AC/TCb: amplification of
AKT3, RICTOR, IGF1R, c-MYC, and p53 mutation
What are her therapeutic options now?

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Capecitabine Monotherapy in Pretreated

Advanced Breast Cancer
Eligibility
Progressive locally advanced MBC pretreated with
2 chemotherapy regimens including previous paclitaxel
or docetaxel

Intervention
Capecitabine 1250 mg/m2 PO BID on Days 1-14 every
3 wks

5. Venturini M, et al. Oncology. 2007;72:51-57.

Chemotherapy After Anthracyclines and Taxane Treatment

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Capecitabine Monotherapy: Efficacy and

Safety Outcomes
Efficacy (N = 349)
ORR: 34.7%
CR: 2.9%
PR: 31.8%
Median TTP: 6.6 mos
Median OS: 10.0 mos

Safety
Adverse events grade 3:
Handfoot syndrome
(7.6%)
Diarrhea (9.0%)
Nausea (1.7%)
Vomiting (2.7%)
Mucositis (1.9%)

5. Venturini M, et al. Oncology. 2007;72:51-57.

Chemotherapy After Anthracyclines and Taxane Treatment

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Eribulin Strongly Disrupts Interphase

Microtubule Dynamics

6. Jordan MA, et al. Mol Cancer Ther. 2005;4:1086-1095.

Chemotherapy After Anthracyclines and Taxane Treatment

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Phase III EMBRACE Trial of Eribulin vs

TPC for Heavily Pretreated MBC
Eligibility criteria:
Locally recurrent or
metastatic breast cancer
2-5 prior chemotherapies:
2 for advanced disease
Prior anthracycline and
taxane
Progression 6 mos since
last chemotherapy
Neuropathy grade 2

R
A
N
D
O
M
I
Z
E
2:1

Primary endpoint: OS
Secondary endpoints: PFS, ORR, safety
7. Cortes J, et al. Lancet. 2011;377:914-923.

Eribulin mesylate 1.4 mg/m2 on

Days 1, 8 every 3 wks
TPC
Any monotherapy approved for
treatment of cancer, radiotherapy, or
supportive care only

Chemotherapy After Anthracyclines and Taxane Treatment

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Phase III EMBRACE Trial: Overall Survival

100

HR: 0.81 (95% CI: 0.66-0.99; P = .041)

Eribulin (n = 508)
TPC (n = 254)
Deaths: 274 (54%), eribulin; 148 (58%), TPC

OS (%)

80
60
40
20
0

OS: 13.1 vs 10.6 mos

PFS: 3.7 vs 2.2 mos

7. Cortes J, et al. Lancet. 2011;377:914-923.

12
16
Mos

20

24

28

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Study 305: EMBRACE Subset Analysis of

OS by Disease Characteristics*
HR (95% CI)

Overall results[8] (n = 762)

Receptor status

ER/PgR+ (n = 528)
ER/PgR- (n = 187)
HER2+ (n = 123)
HER2- (n = 565)
ER/PgR/HER2- (n = 144)

No. of organs
involved

2 (n = 537)
> 2 (n = 217)

Sites of disease

Visceral (n = 624)
Nonvisceral (n = 130)
0.2

0.5

Favors Eribulin

1.0

2.0

5.0

Favors TPC

*Intent-to-treat population; based on a stratified Cox analysis including geographic region, HER2/neu
status, and prior capecitabine therapy as strata. Original analysis based on 55% events in the intent to
treat population[2]
8. Twelves C, et al. SABCS 2010. Abstract P6-14-18. 9. Menis J. Breast Cancer. 2011;3:103-111.

Chemotherapy After Anthracyclines and Taxane Treatment

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Phase III EMBRACE Trial: Grade 3/4

Adverse Events
Eribulin
(n = 503)

TPC
(n = 247)

Neutropenia

45

21

Leukopenia

14

Anemia

Febrile neutropenia

Asthenia/fatigue

10*

Peripheral neuropathy

2*

Nausea

1*

2*

Dyspnea

4*

< 1*

4*

AE, %

Handfoot syndrome
*Grade 3 only.

The incidence of fatal adverse events related to treatment was 1% in both arms

10. Twelves C, et al. ASCO 2010. Abstract CRA1004.

Chemotherapy After Anthracyclines and Taxane Treatment

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Study 301: TNBC Treatment With Eribulin

vs Capecitabine

Open-label, randomized, multicenter phase III study of eribulin mesylate vs

capecitabine in patients with locally advanced or metastatic breast cancer
previously treated with anthracyclines and taxanes
Coprimary endpoint
Eribulin mesylate

Patients (N = 1102)
Locally advanced or
MBC

3 prior chemotherapy
regimens ( 2 for
advanced disease)
Prior anthracycline and
taxane in (neo)adjuvant
setting or for locally
advanced or MBC

1.4 mg/m2 2- to 5-min IV

on Days 1, 8 every 21 days

Capecitabine
1250 mg/m2 BID orally
on Days 1-14 every 21 days

11. Kaufman PA, et al. SABCS 2012. Abstract S6-6.

12. Kaufman PA, et al. J Clin Oncol. 2015;33:594-601.

OS and PFS

Secondary endpoints
Quality of life
ORR
Duration of response
1-, 2-, and 3-yr survival
Tumor-related symptom
assessments
Safety parameters
Population PK/PD

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Study 301 Eribulin vs Capecitabine: OS

Probability of OS

1.0
0.8
0.6

Events/n

Median,
Mos

95% CI

Eribulin

446/554

15.9

15.2-17.6

Capecitabine

459/548

14.5

13.1-16.0

HR: 0.88 (95% CI: 0.77-1.00; P = .056)

0.4
0.2
0

0 4 8 12 16 20 24 28 32 36 40 44 48 52 56 60

Mos
Eribulin vs capecitabine OS rates: 1 yr, 64.4% vs 58.0% (P = .04); 2 yr, 32.8% vs 29.8%
(P = .32); 3 yr, 17.8% vs 14.5% (P = .18)

12. Kaufman PA, et al. J Clin Oncol. 2015;33:594-601.

Chemotherapy After Anthracyclines and Taxane Treatment

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Study 301: OS by Receptor Status in a

Prespecified Subgroup Analysis
Subgroup

HR (95% CI)

Overall

Median OS, Mos

Eribulin

Cape

0.879 (0.770-1.003)

15.9

14.5

Positive

0.965 (0.688-1.355)

14.3

17.1

Negative

0.838 (0.715-0.983)

15.9

13.5

Positive

0.897 (0.737-1.093)

18.2

16.8

Negative

0.779 (0.635-0.955)

14.4

10.5

Yes

0.702 (0.545-0.906)

14.4

9.4

No

0.927 (0.795-1.081)

17.5

16.6

HER2 Status

ER Status

Triple Negative

0.2

0.5
Favors Eribulin

1.0

2.0
Favors Capecitabine

11. Kaufmann P, et al. SABCS 2012. Abstract S6-6.

Chemotherapy After Anthracyclines and Taxane Treatment

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Phase II Eribulin Plus Capecitabine in

MBC

Advanced/
metastatic
breast cancer
(n = 42)
Key inclusion criteria:
Up to 3 prior regimens
(any setting)
Prior anthracycline
(unless CI)
Prior taxane
No prior capecitabine
Measurable tumor disease
PS 0-1

Eribulin 1.4 mg/m2

on Days 1, 8 +
Capecitabine
1000 mg/m2 BID on
Days 1-14 for
21-day cycles
Tumor assessments
performed once every 6 wks

13. Twelves C, et al. SABCS 2014. Abstract P3-13-04.

PD/toxicity/death

Enrollment

End of study visit

within 30 days of last
treatment dose

Endpoints:
ORR
Safety,
tolerability
DOR, CBR
Exploratory:
PK/PD

Chemotherapy After Anthracyclines and Taxane Treatment

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Phase II Eribulin Plus Capecitabine

Prior anthracycline and taxane required
Up to 3 prior chemotherapy regimens
Measurable disease
N = 42 pts
ORR: 43%; CBR (ORR + SD 6 mos): 57%
Median PFS: 7.2 mos (all pts), 7.1 mos (HER2- pts)
Toxicities: 21% grade 1 handfoot syndrome; 5%/8%
grade 2/3 handfoot syndrome
13. Twelves C, et al. SABCS 2014. Abstract P3-13-04. 14. Smith J, et al. SABCS 2014. Abstract P3-09-09.

Chemotherapy After Anthracyclines and Taxane Treatment

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Case Study (contd)

5 mos after radiation and 8 mos s/p AC, then TCb
developed RUQ pain with 7 x 6 cm solitary liver metastasis
Liver biopsy: highly mitotic; triple-negative carcinoma and
NGS: amplification of AKT3, RICTOR, IGF1R, c-MYC and
p53 mutation
Received eribulin plus capecitabine 1500 mg BID 7 on/
7 off with slowly evolving nCR over 10 mos
Underwent resection residual liver metastasis: 1 mm
residual disease with ki67 40%
Continuing eribulin plus capecitabine 2+ yrs with no toxicity

Chemotherapy After Anthracyclines and Taxane Treatment

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Phase II Study: Ixabepilone Monotherapy

in Resistant MBC[16]
Epothilone B analogue
Promotes polymerization of microtubles
Approved as monotherapy for MBC refractory to an
anthracycline, taxane, and capecitabine [15]
Pt eligibility (N = 126)
Tumor progression while receiving prior anthracycline, taxane,
and capecitabine

Intervention
Ixabepilone 40 mg/m2 monotherapy administered as a 3-hr IV
infusion on Day 1 of an every-3-wk cycle
16. Perez EA, et al. J Clin Oncol. 2007;25:3407-3414. 15. Ixabepilone [package insert].

Chemotherapy After Anthracyclines and Taxane Treatment

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Ixabepilone: Efficacy and Safety

Outcomes
Efficacy (N = 113)
OR: 11.5%
SD 6 mos: 13.3%
DOR: 5.7 mos
PFS: 3.1 mos
OS: 8.6 mos

Safety (grade 3/4)

Peripheral sensory
neuropathy (14%)
Fatigue/asthenia (14%)
Myalgia (8%)
Stomatitis/mucositis (7%)
Leukopenia (49%)
Neutropenia (54%)

16. Perez EA, et al. J Clin Oncol. 2007;25:3407-3414.

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Capecitabine Ixabepilone in Pts With

MBC Previously Treated With A/T: OS
Proportion Not Progressed

Phase III trial N = 1221

0.8

Median OS
mos (95% CI)
Ixabepilone + 6.2 (5.6-6.8)
capecitabine

0.6

Capecitabine

1.0

4.4 (4.1-5.4)

0.4
0.2
0

16

24
Mos

17. Sparano JA, et al. J Clin Oncol. 2010;28:3256-3263.

32

40

Chemotherapy After Anthracyclines and Taxane Treatment

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Capecitabine Ixabepilone in Pts With

MBC Previously Treated With A/T: PFS
0.84 (0.68 to 1.04)
0.80 (0.68 to 0.94)
0.82 (0.71 to 0.95)
1.22 (0.63 to 2.38)
0.65 (0.45 to 0.94)
0.64 (0.29 to 1.42)

<50
<50
White
Black
Race
Asian
Other
70-80
KPS
90-100
Mod/Sev liver function at baseline Positive
Other
Yes
Visceral disease
No
Yes
Prior chemo metastatic
No
Yes
Anthracycline resist.
No
Yes
Taxane resistance
No
Positive
HER2 receptor status
Other
Positive
ER Receptor
Other
Yes
ER-PR-HER2No
Age

17. Sparano JA, et al. J Clin Oncol.

2010;28:3256-3263.

0.74 (0.58 to 0.95)

0.83 (0.71 to 0.96)
0.63 (0.39 to 1.01)
0.83 (0.72 to 0.95)
0.82 (0.71 to 0.95)
0.78 (0.59 to 1.03)
0.84 (0.72 to 0.97)
0.64 (0.47 to 0.87)
0.90 (0.70 to 1.16)
0.77 (0.66 to 0.89)
0.85 (0.70 to 1.02)
0.75 (0.63 to 0.91)
0.66 (0.46 to 0.93)
0.84 ( 0.73 to 0.97)
0.96 (0.80 to 1.14)
0.64 (0.53 to 0.78)
0.64 (0.48 to 0.84)
0.86 (0.74 to 1.00)

0.25
Favors I + C

1.0

5.00
Favors C

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Capecitabine Ixabepilone in Metastatic

TNBC: Pooled Analysis
Pooled triple negative subgroup from 2 phase III trials* (n = 443)
Efficacy

Ixa + Cape (n = 191)

Cape (n = 208)

ORR, %

31

15

CR

PR

28

14

Median PFS, mos

4.2

1.7

HR (P value)
Efficacy
Median OS, mos

0.63 (< .0001)

Ixa + Cape (n = 213)

Cape (n = 230)

10.3 (n = 213)

9.0 (n = 230)

HR (P value)
*CA 163-046 and CA 163-048.

18. Rugo HS, et al. SABCS 2008. Abstract 3057.

0.87 (.18)

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Gemcitabine and Carboplatin Iniparib in

Pts With Metastatic TNBC
0.8
0.6
0.4
0.2
0

GC
GCI
Log-rank P = .1114

0 2 4 6 8 10 12 14 1618 20 22 2426
Mos
Pts at Risk, n
GC
GCI

258 239 214 181 151 132 108 87 75 52 26 8 2

261 247 229 203 170 151 130 110 97 66 24 11 1

0
0

ITT
HR: 0.79 (95% CI: 0.65-0.98)
Median PFS, GC/GCI: 4.1/5.1 mos

1.0
Probability of PFS

Probability of OS

1.0

ITT
HR: 0.85 (95% CI: 0.69-1.04)
Median OS, GC/GCI: 11.1/12.2 mos

0.8
0.6
0.4

GC
GCI
Log-rank P = .0271

0.2
0

10

Mos
Pts at Risk, n
GC
258 171 116 63 38 18
GCI 261 187 138 83 53 11

Previous treatment in GC group: 58% first line, 42% second line; 87% prior A/T
ORR GC: 30%
19. OShaughnessy J, et al. J Clin Oncol. 2014;32:3840-3847.

12 14 16
6
2

1
0

0
0

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KEYNOTE-012: Pembrolizumab
in Advanced TNBC: Study Design
Phase Ib study
Pts with recurrent
or metastatic
ER-/PgR-/HER2-,
PD-L1+ BC
(N = 32)

Pembrolizumab
10 mg/kg
q2w

CR

Discontinuation
permitted

PR or SD

Treat for 24 mos

or until PD or intolerable
toxicity

PD

Discontinue

Pembrolizumab: antiPD-1 antibody with high affinity for receptor

Provides dual ligand blockage of PD-L1 and PD-L2
No cytotoxic activity (ADCC/CDC)
Clinical activity in multiple tumor types, recent approval in melanoma
20. Nanda R, et al. SABCS 2014. Abstract S1-09.

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KEYNOTE-012: Pembrolizumab in
Advanced TNBC: Tumor Regression
Change From Baseline in Sum of
Longest Diameter of Target Lesion (%)

Individual Evaluable Pts (n = 23)

100

Confirmed CR (nodal disease)

Confirmed PR
SD
PD

80
60
40
20
0
-20
-40
-60
-80
-100

ORR: 18.5%
Durable responses
Median DOR: not reached (range: 15-40+ wks)
3 responding pts for 11 mos

20. Nanda R, et al. SABCS 2014. Abstract S1-09.

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KEYNOTE-012: Pembrolizumab in
Advanced TNBC: Toxicity
AEs in 5%, %

Pts (N = 32)
Any Grade

Grade 3-5

Arthralgia

18.8

Fatigue

18.8

Myalgia

15.6

Nausea

15.6

ALT increased

6.3

AST increased

6.3

Diarrhea

6.3

Erythema

6.3

Headache

6.3

3.1 (1 pt)

Potentially immune-related AEs (regardless of attribution): pruritus (n = 3; all grade 1/2),

hepatitis (n = 1; grade 3), hypothyroidism (n = 1; grade 2)
20. Nanda R, et al. SABCS 2014. Abstract S1-09.

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Etirinotecan Pegol (NKTR-102)

Polymer conjugate of irinotecan with biodegradable spacer[21]
More active than irinotecan against MCF-7 xenograft[22]
Better tolerated than irinotecan[22,23]

21. Awada A, et al. Lancet Oncol. 2013;14:1216-1225. 22. Hoch U, et al. Cancer Chemother Pharmacol.
2014;74:1125-1137. 23. Jameson GS, et al. Clin Cancer Res. 2013;19:268-278.

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Etirinotecan Pegol: Maximum Decline in

Tumor Measurements*[24]
100
Change in tumor size (%)

80

Phase II study

60
40
20
0

30%
decrease
(RECIST)

-20
-40
-60
-80

-100

7/21 (33%) ORR in TNBC Pts[21]

100%
resolution
of target
lesions

*Includes both dose cohorts.

24. Awada A, et al. IMPAKT 2012. Abstract 101P. 21. Awada A, et al. Lancet Oncol. 2013;14:1216-1225.

Chemotherapy After Anthracyclines and Taxane Treatment

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BEACON: Phase III Trial of Etirinotecan

Pegol (NKTR-102) in HER2-Negative MBC
NKTR-102 IV
every 21 days

HER2-Negative MBC
2 cytotoxic regimens
Prior anthracyclines,
taxanes, and capecitabine

25. ClinicalTrials.gov. NCT01492101.

R
Treatment of
physicians choice

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