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WHEN IS CHEMOTHERAPY AN APPROPRIATE TREATMENT CHOICE
IN HER2-NEGATIVE METASTATIC BREAST CANCER (MBC)?3,4

  • Triple negative breast cancer (TNBC)
  • Hormone receptor (HR) + and hormone refractory/resistant disease
  • Visceral metastases
When selecting chemotherapy in patients with MBC, what characteristics or poor prognostic factors are considered?
Treatment Considerations and Indicators of Poor Prognosis Treatment Considerations and Indicators of Poor Prognosis

ECOG=Eastern Cooperative Oncology Group.

Chart Symbol

Learn More: ABRAXANE’s Phase III Trial Designed to Assess Response Rates
in MBC Patients, Including Those With Poor Prognostic Factors

PATIENTS WHO HAVE MBC WITH VISCERAL AND MULTIPLE
METASTASES OFTEN HAVE LESS FAVORABLE OUTCOMES

There is lower median survival time for patients who develop visceral metastases vs nonvisceral metastases5,a
Patients who have MBC with visceral and multiple metastases often have less favorable outcomes Patients who have MBC with visceral and multiple metastases often have less favorable outcomes
  • A retrospective database analysis of 111 women at a single center in Canada between 2005 and 2007 found that about 67%-73% of patients with metastatic breast cancer (MBC) developed visceral metastases.19 A retrospective analysis of 6 clinical studies between 1983 and 2001 (N=640) found that in 57%-74% of patients, visceral metastases developed as the dominant metastatic site9
  • Further studies demonstrate that up to 85% of patients will develop visceral metastases at some point in the course of their disease7,20-22
  • Visceral metastases are associated with more aggressive MBC compared with nonvisceral metastases; patients tend to have worse outcomes5
The number of metastatic sites is associated with more aggressive MBCa
  • The presence of multiple metastatic lesions or sites is associated with poor prognosis in patients with MBC6
  • Patients with MBC who present metastases at ≥3 sites are likely to have a comparatively less favorable outcome than those with ≤2 metastatic sites8

Univariate survival analysis from a retrospective database of 346 patients diagnosed with MBC after first recurrence between 1970 and 1991.
All patients had undergone surgery for primary breast cancer and may have received radiation, hormonal therapy, and/or chemotherapy for metastatic disease.5

THERE IS LOWER MEDIAN SURVIVAL TIME FOR PATIENTS WITH INCREASING NUMBER OF METASTATIC SITES6,a

Univariate survival analysis of 1430 patients from 8 consecutive prospective trials conducted between 1977 and 1992 of anthracycline-based first-line chemotherapy in MBC. Univariate survival analysis of 1430 patients from 8 consecutive prospective trials conducted between 1977 and 1992 of anthracycline-based first-line chemotherapy in MBC.

Univariate survival analysis of 1430 patients from 8 consecutive prospective trials conducted between 1977 and 1992 of anthracycline-based first-line chemotherapy in MBC.

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Learn More: Majority of Patients From ABRAXANE MBC Phase III Trial Had Multiple and Visceral Metastases

Learn More: Majority of Patients From ABRAXANE MBC Phase III Trial
Had Multiple and Visceral Metastases

BASELINE PATIENT CHARACTERISTICS IN THE ABRAXANE PHASE III STUDY

Baseline patient characteristics in the Abraxane Phase III study Baseline patient characteristics in the Abraxane Phase III study

Study design

Multicenter, 1:1 randomized, Phase III study comparing ABRAXANE 260 mg/m2 IV Q3W with paclitaxel injection 175 mg/m2 IV Q3W in 460 patients with MBC. The primary efficacy endpoint was recTLRR. recTLRR was based on independent radiologic assessment of target lesions reconciled with investigator-reported responses for the first 6 cycles of therapy. The recTLRR was lower than the investigator-reported response rates, which are based on all cycles of therapy. The secondary endpoints were time to disease progression and overall survival.

IV=intravenously; PS=performance status; Q3W=every 3 weeks; recTLRR=reconciled target lesion response rate.

PHASE III RIGOROUS TUMOR RESPONSE ENDPOINT: recTLRR

  • The primary efficacy endpoint: reconciled target lesion response rate (recTLRR)
    • recTLRR was based on independent radiologic assessment of tumor responses
    • recTLRR was reconciled with investigator-reported responses for the first 6 cycles of therapy
  • Secondary efficacy endpoints included time to disease progression and overall survival, among other measures24
  • An exploratory analysis was conducted for overall survival to evaluate the subgroup of patients receiving ABRAXANE as second-line or later therapy

Patients who completed 6 cycles of ABRAXANE therapy and did not progress were able to continue treatment at the investigator's discretion.24

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RECOMMENDATIONS FOR METASTATIC BREAST CANCER PATIENTS WITH VISCERAL METASTASES

The predominance of visceral metastases in the Phase III study is consistent with the National Comprehensive Cancer Network® (NCCN®) recommended* patient population for albumin-bound paclitaxel (ABRAXANE).3

NCCN Guidelines® (V.6.2020) recommend albumin-bound paclitaxel as Category 2A.

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chart symbol

Learn More: ABRAXANE Delivered Almost Double the Response Rates vs
Paclitaxel Injection in MBC

WHEN RESPONSE RATES MATTER, CHOOSE ABRAXANE

Primary endpoint was response rate in ITT population based on reconciled investigator and independent radiologic assessments of target lesions through cycle 6 (recTLRR)a ABRAXANE 260 mg/m2 IV Q3W vs paclitaxel injection 175 mg/m2 IV Q3W

Primary endpoint was response rate in ITT population based on reconciled investigator and independent radiologic assessments of target lesions through cycle 6 (recTLRR)a ABRAXANE 260 mg/m2 IV Q3W vs paclitaxel injection 175 mg/m2 IV Q3W Primary endpoint was response rate in ITT population based on reconciled investigator and independent radiologic assessments of target lesions through cycle 6 (recTLRR)a ABRAXANE 260 mg/m2 IV Q3W vs paclitaxel injection 175 mg/m2 IV Q3W

ITT=intent-to-treat.

recTLRR was the prospectively defined, protocol-specific endpoint, based on independent radiologic assessment of tumor responses reconciled with investigator responses (which also included clinical information) for the first 6 cycles of therapy. The recTLRR was lower than the investigator-reported response rates, which are based on all cycles of therapy.

From Cochran-Mantel-Haenszel test stratified by first-line vs > first-line therapy.

IN RELAPSED OR REFRACTORY METASTATIC BREAST CANCER,
RESPONSE RATES ARE AN IMPORTANT MEASURE

recTLRR: ABRAXANE vs paclitaxel injection for patients who failed combination chemotherapy or relapsed within 6 months of adjuvant chemotherapy (indicated population)

Prior therapy included an anthracycline unless clinically contraindicated. Prior therapy included an anthracycline unless clinically contraindicated.

Prior therapy included an anthracycline unless clinically contraindicated.

MEDIAN TIME TO FIRST CONFIRMED RECONCILED RESPONSE WITH ABRAXANE (EXPLORATORY ENDPOINT FOR ITT)24,a

Median time to first confirmed reconciled response with Abraxane (exploratory endpoint for ITT) Median time to first confirmed reconciled response with Abraxane (exploratory endpoint for ITT)

Analysis Limitations: Time to first reconciled response was an exploratory endpoint that was not powered to determine a treatment difference.

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Median OS

Compare Median Overall Survival (OS) Data: ABRAXANE vs Paclitaxel Injection

MEDIAN OVERALL SURVIVAL DATA:
ABRAXANE VS PACLITAXEL INJECTION23

ITT population: No statistically significant difference between ABRAXANE vs paclitaxel injection; Post-hoc analysis in patients who received at least one prior chemotherapy for metastatic disease ITT population: No statistically significant difference between ABRAXANE vs paclitaxel injection; Post-hoc analysis in patients who received at least one prior chemotherapy for metastatic disease

Median overall survival was measured in weeks and converted to months (assuming 4.348125 weeks in 1 Gregorian month).

Analysis Limitations: A post-hoc exploratory analysis should not be interpreted to determine a treatment difference between arms in this selected subgroup because of potential selection bias, insufficient sample size, and a higher probability of making a false positive finding.

OBSERVED SAFETY PROFILE
MOST COMMON ADVERSE EVENTS IN >20% OF PATIENTS

Observed safety profile most common adverse events in >20% of patients Observed safety profile most common adverse events in >20% of patients

AST=aspartate aminotransferase; ECG=electrocardiogram;
SGOT=serum glutamic-oxaloacetic transaminase.

Paclitaxel injection patients received premedication.

Severe events are defined as at least Grade 3 toxicity.

OBSERVED SAFETY PROFILE
ADVERSE EVENTS IN A PHASE III CLINICAL TRIAL

Frequencya of important treatment-emergent adverse events in the randomized study of an every-3-week schedule

 

Frequencya of important treatment-emergent adverse events in the randomized study of an every-3-week schedule

PERCENTAGE OF PATIENTS
ABRAXANE 260 mg/m2 over 30 min (n=229)
Paclitaxel injection 175 mg/m2 over 3 hb (n=225)
HEMATOLOGIC    
BONE MARROW    
Neutropenia    
<2.0 x 109/L 80 82
<0.5 x 109/L (Grade 4) 9 22
Thrombocytopenia    
<100 x 109/L 23
<50 x 109/L (Grade ≥3) <1 <1
Anemia    
<11 g/dL 33 25
<8 g/dL (Grade ≥3) 1<1
Infections 24 20
Febrile Neutropenia 2 1
Neutropenic Sepsis <1 <1
Bleeding 2 2
NONHEMATOLOGIC    
HYPERSENSITIVITY REACTIONc    
All 4 12
Severed 0 2
CARDIOVASCULAR    
Vital Sign Changes During Administration    
Bradycardia <1 <1
Hypotension 5 5
Severe Cardiovascular Eventsd 3 4
ABNORMAL ECG    
All Patients 60 52
Patients With Normal Baseline 35 30
RESPIRATORY    
Cough 7 6
Dyspnea 12 9
SENSORY NEUROPATHY    
Any Symptoms 71 56
Severe Symptomsd 10 2
MYALGIA/ARTHRALGIA    
Any Symptoms 44 49
Severe Symptomsd 8 4
ASTHENIA    
Any Symptoms 47 39
Severe Symptomsd 8 3
FLUID RETENTION/EDEMA    
Any Symptoms 10 8
Severe Symptomsd 0 <1
GASTROINTESTINAL    
Nausea    
Any Symptoms 30 22
Severe Symptomsd 3 <1
Vomiting    
Any Symptoms 18 10
Severe Symptomsd 4 1
Diarrhea    
Any Symptoms 27 15
Severe Symptomsd <1 1
Mucositis    
Any Symptoms 7 6
Severe Symptomsd <1 0
ALOPECIA 90 94
HEPATIC (PATIENTS WITH NORMAL BASELINE)    
Bilirubin Elevations 7 7
Alkaline Phosphatase Elevations 36 31
AST (SGOT) Elevations 39 32
INJECTION-SITE REACTION <1 1

NCI=National Cancer Institute.

Based on worst grade by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 2.

Paclitaxel injection patients received premedication.

Includes treatment-related events related to hypersensitivity (eg, flushing, dyspnea, chest pain, hypotension) that began on a day of dosing.

Severe events are defined as at least Grade 3 toxicity.

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Patient and Healthcare Resources

Download the “Preparing for My Treatment” Brochure: Help Your
Patients With MBC Get Ready for Their Medical Appointments

UNDERSTANDING AND ADDRESSING NEUROPATHY
ABRAXANE PHASE III MBC TRIAL

71% of 229 patients who received ABRAXANE developed Grades 1-3 sensory neuropathy (no Grade 4 was reported)

ABRAXANE® for metastatic breast cancer (MBC) - Grade 3 neuropathy from the phase III trial: 10% of patients developed Grade 3 neuropathy, 22 days median time to documented improvement for 14 of the 24 patients with Grade 3 neuropathy. Of the 10 patients without documented improvement, 4 discontinued due to peripheral neuropathy. 42% of patients resumed ABRAXANE® at a reduced dose - chart ABRAXANE® for metastatic breast cancer (MBC) - Grade 3 neuropathy from the phase III trial: 10% of patients developed Grade 3 neuropathy, 22 days median time to documented improvement for 14 of the 24 patients with Grade 3 neuropathy. Of the 10 patients without documented improvement, 4 discontinued due to peripheral neuropathy. 42% of patients resumed ABRAXANE® at a reduced dose - chart
  • The frequency and severity of sensory neuropathy increased with cumulative doses of ABRAXANE
    • 3% of patients (7/229) discontinued treatment with ABRAXANE due to sensory neuropathy
  • Only 1 incident of motor neuropathy (Grade 2) was observed in either arm of the controlled trial
Learn about dose modifications for treatment-related Neuropathy

Learn About Dose Modifications for Treatment-related Neuropathy

UNDERSTANDING AND ADDRESSING NEUTROPENIA
ABRAXANE PHASE III MBC TRIAL

ABRAXANE® for metastatic breast cancer (MBC) incidences of neutropenia from the phase III trial: Grade 1-4 ABRAXANE® (80%) vs paclitaxel (82%), Grade 4 ABRAXANE® (9%) vs paclitaxel 22%, febrile neutropenia ABRAXANE® (2%) vs paclitaxel (1%). 34% of patients receiving ABRAXANE® experienced Grade 3-4 neutropenia - chart ABRAXANE® for metastatic breast cancer (MBC) incidences of neutropenia from the phase III trial: Grade 1-4 ABRAXANE® (80%) vs paclitaxel (82%), Grade 4 ABRAXANE® (9%) vs paclitaxel 22%, febrile neutropenia ABRAXANE® (2%) vs paclitaxel (1%). 34% of patients receiving ABRAXANE® experienced Grade 3-4 neutropenia - chart
Learn about dose modifications for treatment-related Neutropenia

Learn About Dose Modifications For Treatment-related Neutropenia

UNDERSTANDING DURATION AND DOSING
ABRAXANE PHASE III MBC TRIAL

Patients treated with ABRAXANE received a median of 6 cycles of therapy

The primary endpoint, recTLRR, was the evaluation of reponses achieved in the first 6 cycles of therapy
  • The primary endpoint, recTLRR, was the evaluation of responses achieved in the first 6 cycles of therapy

FDA-approved dose and schedule for ABRAXANE in metastatic breast cancer:

  • Administer intravenously at a dose of 260 mg/m2
  • Recommended schedule is once every 3 weeks
  • Administer over 30 minutes
  • Premedication to prevent hypersensitivity reactions is generally not needed prior to the administration of ABRAXANE. Premedication may be needed in patients who have had prior hypersensitivity reactions to ABRAXANE. Patients who experience a severe hypersensitivity reaction to ABRAXANE should not be rechallenged with this drug
Watch the ABRAXANE
Reconstitution Video

DOSE MODIFICATIONS
FOR PATIENTS WITH HEPATIC IMPAIRMENT

Recommendations for starting dose in patients with hepatic impairment

SGOT (AST) LEVELS
<10 x ULN
AND BILIRUBIN LEVELS
> ULN TO ≤1.5 x ULN

SGOT (AST) LEVELS
<10 x ULN
AND BILIRUBIN LEVELS
> 1.5 TO ≤3 x ULN

SGOT (AST) LEVELS
<10 x ULN
AND BILIRUBIN LEVELS
> 3 TO ≤5 x ULN

SGOT (AST) LEVELS
>10 x ULN
AND BILIRUBIN LEVELS
>5 x ULN

MILD

MODERATE

SEVERE


Mild

  • No dose adjustment is necessary for patients with mild hepatic impairment
  • Do not administer ABRAXANE to patients with total bilirubin >5 x ULN or AST >10 x ULN
  • Dosage recommendations are for the first course of therapy. The need for further dose adjustments in subsequent courses should be based on individual tolerance

Moderate

  • Do not administer ABRAXANE to patients with total bilirubin >5 x ULN or AST >10 x ULN
  • Dosage recommendations are for the first course of therapy. The need for further dose adjustments in subsequent courses should be based on individual tolerance

Severe

  • Do not administer ABRAXANE to patients with total bilirubin >5 x ULN or AST >10 x ULN
  • Dosage recommendations are for the first course of therapy. The need for further dose adjustments in subsequent courses should be based on individual tolerance
  • Do not administer ABRAXANE to patients with total bilirubin >5 x ULN or AST >10 x ULN

ABRAXANE dose

ABRAXANE 260 mg/m2 dose illustration ABRAXANE 200 mg/m2 dose illustration ABRAXANE 200 mg/m2 dose illustration Not Recommended ABRAXANE dosing icon

ILLUSTRATIVE PURPOSES ONLY

A dose increase to 260 mg/m2 in subsequent courses should be considered if the patient tolerates the reduced dose for 2 cycles.

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DOSING FOR YOUR PATIENTS
WHO EXPERIENCE SENSORY NEUROPATHY

ABRAXANE dose-modification schedule for neuropathy

MILD TO MODERATE

SEVERE

RECURRENT


Mild to Moderate

The occurrence of Grade 1 or 2 sensory neuropathy does not generally require dose modification

  • In the Phase III ABRAXANE MBC clinical trial, sensory neuropathy with any symptoms occurred in 71% of patients receiving ABRAXANE 260 mg/m2 over 30 minutes; sensory neuropathy with severe symptoms (defined as ≥ Grade 3 toxicity) occurred in 10% of patients receiving ABRAXANE

Severe

If ≥ Grade 3 sensory neuropathy develops, hold until resolution to Grade 1 or 2 followed by a dose reduction for all subsequent courses of ABRAXANE

  • In the Phase III ABRAXANE MBC clinical trial, sensory neuropathy with any symptoms occurred in 71% of patients receiving ABRAXANE 260 mg/m2 over 30 minutes; sensory neuropathy with severe symptoms (defined as ≥ Grade 3 toxicity) occurred in 10% of patients receiving ABRAXANE

Recurrent

If severe (≥ Grade 3) neuropathy is recurrent, hold treatment until resolution to Grade 1 or 2, then reduce dose from 220 mg/m2 to 180 mg/m2 for all subsequent courses

  • In the Phase III ABRAXANE MBC clinical trial, sensory neuropathy with any symptoms occurred in 71% of patients receiving ABRAXANE 260 mg/m2 over 30 minutes; sensory neuropathy with severe symptoms (defined as ≥ Grade 3 toxicity) occurred in 10% of patients receiving ABRAXANE
  • Do not administer ABRAXANE to patients with total bilirubin >5 x ULN or AST >10 x ULN

ABRAXANE dose

ABRAXANE 260 mg/m2 dose illustration ABRAXANE 220 mg/m2 dose illustration ABRAXANE 180 mg/m2 dosing illustration

ILLUSTRATIVE PURPOSES ONLY

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DOSING FOR YOUR PATIENTS
WHO EXPERIENCE NEUTROPENIA

ABRAXANE dose-modification schedule for neutropenia

MILD TO MODERATE

SEVERE

RECURRENT


Mild to Moderate

  • If neutropenia is mild or moderate (Grade 1 or 2), no dose reduction is needed
  • ABRAXANE has a dose-reduction schedule for patients who experience severe neutropenia
  • Monitor for myelotoxicity by performing complete blood cell counts frequently, including prior to dosing on Day 1
  • In the Phase III ABRAXANE MBC clinical trial, neutropenia (<2.0 x 109/L) occurred in 80% of patients receiving ABRAXANE 260 mg/m2 over 30 minutes; neutropenia (<0.5 x 109/L) occurred in 9% of patients receiving ABRAXANE

Severe

  • If neutropenia is severe (neutrophils <500 cells/mm3 for 7 days or longer), reduce dose from 260 mg/m2 to 220 mg/m2 for subsequent courses
  • ABRAXANE has a dose-reduction schedule for patients who experience severe neutropenia
  • Monitor for myelotoxicity by performing complete blood cell counts frequently, including prior to dosing on Day 1
  • In the Phase III ABRAXANE MBC clinical trial, neutropenia (<2.0 x 109/L) occurred in 80% of patients receiving ABRAXANE 260 mg/m2 over 30 minutes; neutropenia (<0.5 x 109/L) occurred in 9% of patients receiving ABRAXANE

Recurrent

  • If severe neutropenia is recurrent, reduce dose from 220 mg/m2 to 180 mg/m2 for subsequent courses
  • ABRAXANE has a dose-reduction schedule for patients who experience severe neutropenia
  • Monitor for myelotoxicity by performing complete blood cell counts frequently, including prior to dosing on Day 1
  • In the Phase III ABRAXANE MBC clinical trial, neutropenia (<2.0 x 109/L) occurred in 80% of patients receiving ABRAXANE 260 mg/m2 over 30 minutes; neutropenia (<0.5 x 109/L) occurred in 9% of patients receiving ABRAXANE
  • Do not administer ABRAXANE to patients with total bilirubin >5 x ULN or AST >10 x ULN

ABRAXANE dose

ABRAXANE 260 mg/m2 dose illustration ABRAXANE 220 mg/m2 dosing illustration ABRAXANE 180 mg/m2 dosing illustration

ILLUSTRATIVE PURPOSES ONLY

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THE MAJORITY OF PATIENTS IN BOTH ARMS HAD POOR PROGNOSTIC FACTORS

  • 79%
    had visceral metastases
  • 76%
    >3 sites of metastases

ABRAXANE ALMOST DOUBLED THE RESPONSE RATE (recTLRR) VS PACLITAXEL IN THE ITT POPULATION

ABRAXANE almost doubled the response rate (recTLRR) vs paclitaxel in the ITT population ABRAXANE almost doubled the response rate (recTLRR) vs paclitaxel in the ITT population
  • Indication population:
    15.5% (n=20/129 [95% CI: 9.26%-21.75%]) vs
    8.4% (n=12/143 [95% CI: 3.85%-12.94%])

From Cochran-Mantel-Haenszel test stratified by first-line vs > first-line therapy.

MEDIAN OVERALL SURVIVAL23

ITT: No significant difference in OS between treatments; ≥ One prior therapy: Post-hoc exploratory analysis ITT: No significant difference in OS between treatments; ≥ One prior therapy: Post-hoc exploratory analysis

Analysis Limitations: A post-hoc exploratory analysis should not be interpreted to determine a treatment difference between arms in this selected subgroup because of potential selection bias, insufficient sample size, and a higher probability of making a false positive finding.

Median overall survival was measured in weeks and converted to months (assuming 4.348125 weeks in 1 Gregorian month).

MOST COMMON AEs (≥20%)

  • Alopecia
  • Neutropenia
  • Sensory Neuropathy
  • Abnormal ECG
  • Fatigue/Asthenia
  • Myalgia/Arthralgia
  • AST Elevations
  • Alkaline Phosphatase Elevations
  • Anemia
  • Nausea
  • Infections
  • Diarrhea

Study design

Multicenter, 1:1 randomized, Phase III study comparing ABRAXANE 260 mg/m2 IV Q3W with paclitaxel injection 175 mg/m2 IV Q3W in 460 patients with MBC. The primary efficacy endpoint was recTLRR. recTLRR was based on independent radiologic assessment of target lesions reconciled with investigator-reported responses for the first 6 cycles of therapy. The recTLRR was lower than the investigator-reported response rates, which are based on all cycles of therapy. The secondary endpoints were time to disease progression and overall survival.

Healthcare Professional Resources

Healthcare Professional Resources
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Patient Resources

Patient Resources
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References: 1. Paclitaxel. Package insert. Hospira, Inc; 2018. 2. Taxotere. Package insert. Sanofi-Aventis U.S. LLC; 2020. 3. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V.6.2020. © National Comprehensive Cancer Network, Inc. 2020. All rights reserved. Accessed September 15, 2020. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 4. Cardoso F, Costa A, Norton L, et al. ESO-ESMO 2nd international consensus guidelines for advanced breast cancer (ABC2). Ann Oncol. 2014;25(10):1871-1888. 5. Chang J, Clark GM, Allred DC, Mohsin S, Chamness G, Elledge RM. Survival of patients with metastatic breast carcinoma: importance of prognostic markers of the primary tumor. Cancer. 2003;97(3):545-553. 6. Pierga JY, Robain M, Jouve M, et al. Response to chemotherapy is a major parameter-influencing long-term survival of metastatic breast cancer patients. Ann Oncol. 2001;12(2):231-237. 7. Sledge GW, Neuberg D, Bernardo P, et al. Phase Ill trial of doxorubicin, paclitaxel, and the combination of doxorubicin and paclitaxel as front-line chemotherapy for metastatic breast cancer: an intergroup trial (E1193). J Clin Oncol. 2003;21(14):588-592. 8. Jung SY, Rosenzweig M, Sereika SM, Linkov F, Brufsky A, Weissfeld JL. Factors associated with mortality after breast cancer metastasis. Cancer Causes Control. 2012;23(1):103-112. 9. Gennari A, Conte P, Rosso R, Orlandini C, Bruzzi P. Survival of metastatic breast carcinoma patients over a 20-year period: a retrospective analysis based on individual patient data from six consecutive studies. Cancer. 2005;104(8):1742-1750. 10. Lobbezoo DJA, van Kampen RJW, Voogd AC, et al. Prognosis of metastatic breast cancer subtypes: the hormone receptor/HER2-positive subtype is associated with the most favorable outcome. Breast Cancer Res Treat. 2013;141(3):507-514. 11. Yamamoto N, Watanabe T, Katsumata N, et al. Construction and validation of a practical prognostic index for patients with metastatic breast cancer. J Clin Oncol. 1998;16(7):2401-2408. 12. Thientosapol ES, Tran TT, Della-Fiorentina SA, et al. Survival times of women with metastatic breast cancer starting first-line chemotherapy in routine clinical practice versus contemporary randomised trials. Intern Med J. 2013;43(8):883-888. 13. Harris LN, Broadwater G, Lin NU, et al. Molecular subtypes of breast cancer in relation to paclitaxel response and outcomes in women with metastatic disease: results from CALGB 9342. Breast Cancer Res. 2006;8(6):R66. 14. Chung M, Chang HR, Bland KI, Wanebo HJ. Younger women with breast carcinoma have a poorer prognosis than older women. Cancer. 1996;77(1):97-103. 15. Clark GM, Sledge GW Jr, Osborne CK, McGuire WL. Survival from first recurrence: relative importance of prognostic factors in 1,015 breast cancer patients. J Clin Oncol. 1987;5(1):55-61. 16. Azim HA Jr, Michiels S, Bedard PL, et al. Elucidating prognosis and biology of breast cancer arising in young women using gene expression profiling. Clin Cancer Res. 2012;18(5):1341-1351. 17. DeSantis CE, Fedewa SA, Sauer A, Kramer JL, Jemal A. Breast cancer statistics, 2015: convergence of incidence rates between black and white women. CA Cancer J Clin. 2016;66(1):31-42. 18. American Cancer Society. Cancer Facts & Figures for African Americans 2018. Atlanta, GA: American Cancer Society, 2018. 19. Samiee S, Berardi P, Bouganim N, et al. Excision of the primary tumour in patients with metastatic breast cancer: a clinical dilemma. Curr Oncol. 2012;19(4):e270-e279. 20. Wallwiener M, Hartkopf AD, Baccelli I, et al. The prognostic impact of circulating tumor cells in subtypes of metastatic breast cancer. Breast Cancer Res Treat. 2013;137(2):503-510. 21. Loibl S, Doering G, Müller L, et al. Multicenter phase II study with weekly bendamustine and paclitaxel as first- or later-line therapy in patients with metastatic breast cancer: RiTa II trial. Breast Care (Basel). 2011;6(6):457-461. 22. Villanueva C, Chaigneau L, Dufresne A, et al. Phase II trial of paclitaxel and uracil-tegafur in metastatic breast cancer. TEGATAX trial. Breast. 2011;20(4):329-333. 23. Gradishar WJ, Tjulandin S, Davidson N, et al. Phase Ill trial of nanoparticle albumin-bound paclitaxel compared with polyethylated castor oil–based paclitaxel in women with breast cancer. J Clin Oncol. 2005;23(31):7794-7803. 24. Data on file. Bristol-Myers Squibb Company.