1st or 2nd Line MBC (Metastatic Breast Cancer) With Previ... | NCT00493636

NCT00493636

Status Module

Sponsor/Collaborators Module

Name	Class
Amgen	INDUSTRY

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A (Sorafenib + Gemcitabine or Capecitabine)	Active Comparator	Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)	Drug: Gemcitabine Drug: Sorafenib Drug: Capecitabine
B (Placebo + Gemcitabine or Capecitabine)	Placebo Comparator	Placebo will be administered ( 2 tablets ) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)	Drug: Gemcitabine Drug: Placebo Drug: Capecitabine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gemcitabine	Drug	Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle	A (Sorafenib + Gemcitabine or Capecitabine) B (Placebo + Gemcitabine or Capecitabine)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression Free Survival		From the date of randomization to date of first documented disease progression (i.e., the date on which a radiologic procedure or clinical evaluation was performed) or the date of death due to any cause, if before progression, assessed up to 39 months.

Secondary Outcomes

Measure	Description	Time Frame
Overall Survival		From the date of randomization to date of death due to any cause, assessed up to 56 months.
Time to Progression		Calculated as the time (days) from date of randomization to date of first observed disease progression (radiological or clinical, whichever is earlier), assessed up to 39 months.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically or cytologically confirmed adenocarcinoma of the breast.
Measurable or evaluable locally advanced or metastatic disease.
Age ≥18 years.
Disease progression during or after treatment with a bevacizumab-containing regimen in the adjuvant or first-line metastatic setting.
Patients must have discontinued chemotherapy at least 3 weeks prior to randomization.
No more than one prior chemotherapy regimen for locally advanced or metastatic disease.
Prior hormonal therapy allowed provided it has been discontinued prior to randomization.
Prior radiation therapy is allowed but must be completed at least 3 weeks prior to randomization. Previously radiated area(s) must not be the only site of disease.
ECOG Performance Status of 0 or 1.
Adequate bone marrow, liver, and renal function
Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to randomization, and must agree to use adequate contraception prior to study entry, for the duration of study participation and 28 days after the last study drug dosing.
Patients must be able and willing to sign a written informed consent.
Patients must be able to swallow and retain oral medication.

Exclusion Criteria:

Patients with breast cancer over-expressing human epidermal growth factor receptor 2 (HER-2) (gene amplification by FISH or 3+ over-expression by immunohistochemistry). Patients with unknown HER-2 status are not eligible.
Patients with active brain metastases.
Major surgery, open biopsy, or significant traumatic injury within 4 weeks of randomization.
Prior use of gemcitabine/capecitabine or sorafenib.
Evidence or history of bleeding diathesis or coagulopathy.
Serious, non-healing wound, ulcer, or bone fracture.
Substance abuse, or medical, psychological, or social condition that may interfere with the patient's participation in the study or evaluation of the study results.
Use of cytochrome P450 enzyme-inducing anti-epileptic drugs is not allowed.
Clinically significant cardiac disease
Uncontrolled hypertension
Thrombolic, embolic, venous, or arterial events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.
Pulmonary hemorrhage/bleeding event > NCI-CTCAE Grade 2 within 4 weeks of randomization.
Any other hemorrhage/bleeding event ≥ NCI-CTCAE Grade 3 within 4 weeks of randomization.
Active clinically serious infection > NCI-CTCAE Grade 2.
Known HIV infection or chronic hepatitis B or C (the safety and effectiveness of sorafenib in this patient population have not been studied).
Previous or concurrent cancer that is distinct in primary site or histology from breast cancer EXCEPT cervical cancer in-situ, treated basal cell carcinoma, superficial bladder tumors [Ta and Tis] or any cancer curatively treated > 5 years prior to randomization.
Known or suspected allergy to sorafenib or gemcitabine/capecitabine.
Prior or concurrent use of St. John's Wort or rifampin (rifampicin) within 3 weeks of randomization.
Concurrent anti-cancer therapy other than gemcitabine/capecitabine and sorafenib/placebo.
Prior treatment with any agent that targets VEGF or VEGFR (licensed or investigational), except bevacizumab.
Women who are pregnant or breast-feeding.
Use of any investigational drug within 30 days or 5 half-lives, whichever is longer, preceding randomization.
Inability to comply with protocol and/or not willing or not available for follow-up assessments.
Any condition which in the investigator's opinion makes the patient unsuitable for the study participation.

Contacts/Locations Module

Name	Affiliation	Role
Lee S Schwartzberg, MD, FACP	Accelerated Community Oncology Research Network Inc	Study Chair
Clifford A Hudis, MD	Memorial Sloan Kettering Cancer Center	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Providence Cancer Center / Katmai Oncology Group LLC		Anchorage	Alaska	99508	United States
Highlands Oncology Group

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23444220	Derived	Schwartzberg LS, Tauer KW, Hermann RC, Makari-Judson G, Isaacs C, Beck JT, Kaklamani V, Stepanski EJ, Rugo HS, Wang W, Bell-McGuinn K, Kirshner JJ, Eisenberg P, Emanuelson R, Keaton M, Levine E, Medgyesy DC, Qamar R, Starr A, Ro SK, Lokker NA, Hudis CA. Sorafenib or placebo with either gemcitabine or capecitabine in patients with HER-2-negative advanced breast cancer that progressed during or after bevacizumab. Clin Cancer Res. 2013 May 15;19(10):2745-54. doi: 10.1158/1078-0432.CCR-12-3177. Epub 2013 Feb 26.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	A (Sorafenib + Gemcitabine or Capecitabine)	Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine) Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle Sorafenib: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours) Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine).

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

All randomized patients are included (i.e., the intent-to-treat population)

Arm/Group Information

ID	Title	Description
BG000	A (Sorafenib + Gemcitabine or Capecitabine)	Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine) Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle Sorafenib: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours) Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine).
BG001	B (Placebo + Gemcitabine or Capecitabine)	Placebo will be administered ( 2 tablets ) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine) Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle Placebo: Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours) Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine).
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00053.5± 10.6 BG00154.2± 11.0 BG00253.8± 10.8

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00081 BG00179 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00081 BG00179 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Progression Free Survival

Posted

Median

95% Confidence Interval

Days

From the date of randomization to date of first documented disease progression (i.e., the date on which a radiologic procedure or clinical evaluation was performed) or the date of death due to any cause, if before progression, assessed up to 39 months.

ID	Title	Description
OG000	A (Sorafenib + Gemcitabine or Capecitabine)	Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine) Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle Sorafenib: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours) Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine).
OG001	B (Placebo + Gemcitabine or Capecitabine)	Placebo will be administered ( 2 tablets ) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine) Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle Placebo: Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours) Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine).

Units	Counts
Participants	OG00081 OG00179

Title

Denominators

Categories

Title	Measurements
	OG000103(83 to 128) OG00181(48 to 95)

Secondary

Overall Survival

Posted

Median

95% Confidence Interval

Days

From the date of randomization to date of death due to any cause, assessed up to 56 months.

ID	Title	Description
OG000	A (Sorafenib + Gemcitabine or Capecitabine)	Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine) Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle Sorafenib: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours) Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine).
OG001	B (Placebo + Gemcitabine or Capecitabine)	Placebo will be administered ( 2 tablets ) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine) Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle Placebo: Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours) Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine).

Secondary

Time to Progression

Posted

Median

95% Confidence Interval

Days

Calculated as the time (days) from date of randomization to date of first observed disease progression (radiological or clinical, whichever is earlier), assessed up to 39 months.

ID	Title	Description
OG000	A (Sorafenib + Gemcitabine or Capecitabine)	Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine) Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle Sorafenib: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours) Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine).
OG001	B (Placebo + Gemcitabine or Capecitabine)	Placebo will be administered ( 2 tablets ) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine) Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle Placebo: Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours) Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine).

Secondary

Overall Response Rate

Overall response rate was defined as the proportion of participants experiencing complete response (CR) and partial response (PR) as best overall response. Response was evaluated via changes from baseline in radiological tumor measurements using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter (LD) of target lesions; Stable Disease (SD) is neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of >=20%; Progressive Disease (PD) is the increase in existing lesions or new lesions.

Posted

Number

percentage of participants

The overall tumor burden at baseline will be compared with subsequent measurements up to the date of first documented disease progression or the date of death due to any cause, if before progression, assessed up to 39 months.

ID	Title	Description
OG000	A (Sorafenib + Gemcitabine or Capecitabine)	Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine) Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle Sorafenib: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours) Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine).

Secondary

Duration of Overall Response

Duration of overall response was calculated as the time (days) from first documentation of CR or PR (whichever status is recorded first) until the first date that recurrent or progressive disease (PD) or death is objectively documented. Response was evaluated via changes from baseline in radiological tumor measurements using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter (LD) of target lesions; Stable Disease (SD) is neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of >=20%; Progressive Disease (PD) is the increase in existing lesions or new lesions.

Posted

Median

95% Confidence Interval

Days

Period measured from the first documentation of complete or partial response (whichever status is recorded first) until the first date that recurrent or progressive disease or death is objectively documented.

ID	Title	Description
OG000	A (Sorafenib + Gemcitabine or Capecitabine)	Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine) Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle Sorafenib: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours) Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine).

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	A (Sorafenib + Gemcitabine or Capecitabine)	Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine) Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle Sorafenib: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours) Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine).			32	79	78	79
EG001	B (Placebo + Gemcitabine or Capecitabine)	Placebo will be administered ( 2 tablets ) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine) Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle Placebo: Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours) Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine).			28	77	73	77

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Vomiting	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0003 affected79 at risk EG0012 affected77 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected79 at risk EG0013 affected77 at risk
Nausea	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 affected79 at risk EG0012 affected77 at risk
Diarrhea	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 affected79 at risk EG0011 affected77 at risk
Constipation	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected79 at risk EG0012 affected77 at risk
Stomatitis	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 affected79 at risk EG0010 affected77 at risk
Pneumonia	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0002 affected79 at risk EG0015 affected77 at risk
Cellulitis	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected79 at risk EG0012 affected77 at risk
Disease progression	General disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 affected79 at risk EG0012 affected77 at risk
Pyrexia	General disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected79 at risk EG0013 affected77 at risk
Fatigue	General disorders	MedDRA (10.0)	Non-systematic Assessment	EG0003 affected79 at risk EG0010 affected77 at risk
Mucosal inflammation	General disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 affected79 at risk EG0010 affected77 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 affected79 at risk EG0012 affected77 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0003 affected79 at risk EG0011 affected77 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected79 at risk EG0012 affected77 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 affected79 at risk EG0010 affected77 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected79 at risk EG0012 affected77 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (10.0)	Non-systematic Assessment	EG0004 affected79 at risk EG0011 affected77 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 affected79 at risk EG0010 affected77 at risk
Aspartate aminotransferase increased	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG0002 affected79 at risk EG0010 affected77 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nausea	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG00035 affected79 at risk EG00138 affected77 at risk
Diarrhea	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG00029 affected79 at risk EG00117 affected77 at risk
Constipation	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG00018 affected79 at risk EG00121 affected77 at risk
Vomiting	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG00021 affected79 at risk EG00118 affected77 at risk
Stomatitis	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG00021 affected79 at risk EG0015 affected77 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG00011 affected79 at risk EG00110 affected77 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0004 affected79 at risk EG0015 affected77 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0004 affected79 at risk EG0014 affected77 at risk
Fatigue	General disorders	MedDRA (10.0)	Systematic Assessment	EG00049 affected79 at risk EG00138 affected77 at risk
Pyrexia	General disorders	MedDRA (10.0)	Systematic Assessment	EG00015 affected79 at risk EG00116 affected77 at risk
Pain	General disorders	MedDRA (10.0)	Systematic Assessment	EG00011 affected79 at risk EG0018 affected77 at risk
Mucosal inflammation	General disorders	MedDRA (10.0)	Systematic Assessment	EG00011 affected79 at risk EG0015 affected77 at risk
Edema peripheral	General disorders	MedDRA (10.0)	Systematic Assessment	EG0007 affected79 at risk EG0015 affected77 at risk
Chest pain	General disorders	MedDRA (10.0)	Systematic Assessment	EG0006 affected79 at risk EG0015 affected77 at risk
Chills	General disorders	MedDRA (10.0)	Systematic Assessment	EG0005 affected79 at risk EG0014 affected77 at risk
Asthenia	General disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected79 at risk EG0015 affected77 at risk
Influenza like illness	General disorders	MedDRA (10.0)	Systematic Assessment	EG0004 affected79 at risk EG0011 affected77 at risk
Palmar-plantar erythrodysesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG00045 affected79 at risk EG00114 affected77 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG00022 affected79 at risk EG00113 affected77 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0006 affected79 at risk EG0015 affected77 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0007 affected79 at risk EG0013 affected77 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG00017 affected79 at risk EG00119 affected77 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG00018 affected79 at risk EG00116 affected77 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG00013 affected79 at risk EG0019 affected77 at risk
Pharyngolaryngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0007 affected79 at risk EG0015 affected77 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0006 affected79 at risk EG0013 affected77 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0006 affected79 at risk EG0012 affected77 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0009 affected79 at risk EG00114 affected77 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0009 affected79 at risk EG00114 affected77 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG00015 affected79 at risk EG0017 affected77 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected79 at risk EG0015 affected77 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0004 affected79 at risk EG0013 affected77 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Systematic Assessment	EG0005 affected79 at risk EG0011 affected77 at risk
Headache	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG00019 affected79 at risk EG00114 affected77 at risk
Dizziness	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0005 affected79 at risk EG00110 affected77 at risk
Neuropathy	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0006 affected79 at risk EG0012 affected77 at risk
Dysgeusia	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0005 affected79 at risk EG0011 affected77 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0004 affected79 at risk EG0012 affected77 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected79 at risk EG0015 affected77 at risk
Paresthesia	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected79 at risk EG0014 affected77 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG00019 affected79 at risk EG00121 affected77 at risk
Anemia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG00012 affected79 at risk EG0016 affected77 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG00010 affected79 at risk EG0018 affected77 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA (10.0)	Systematic Assessment	EG0005 affected79 at risk EG0015 affected77 at risk
Weight decreased	Investigations	MedDRA (10.0)	Systematic Assessment	EG00011 affected79 at risk EG0013 affected77 at risk
Aspartate aminotransferase increased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0004 affected79 at risk EG0017 affected77 at risk
Alanine aminotransferase increased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0005 affected79 at risk EG0015 affected77 at risk
Neutrophil count decreased	Investigations	MedDRA (10.0)	Systematic Assessment	EG0005 affected79 at risk EG0013 affected77 at risk
Hemoglobin abnormal	Investigations	MedDRA (10.0)	Systematic Assessment	EG0002 affected79 at risk EG0014 affected77 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG00015 affected79 at risk EG0017 affected77 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0007 affected79 at risk EG0014 affected77 at risk
Hypokalemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0005 affected79 at risk EG0013 affected77 at risk
Hyperglycemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected79 at risk EG0014 affected77 at risk
Pneumonia	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0002 affected79 at risk EG0016 affected77 at risk
Sinusitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0004 affected79 at risk EG0012 affected77 at risk
Hypertension	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG00016 affected79 at risk EG0017 affected77 at risk
Hot flush	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0006 affected79 at risk EG0013 affected77 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0005 affected79 at risk EG0011 affected77 at risk
Anxiety	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected79 at risk EG0016 affected77 at risk
Insomnia	Psychiatric disorders	MedDRA (10.0)	Systematic Assessment	EG0003 affected79 at risk EG0014 affected77 at risk

ID	Term
D001943	Breast Neoplasms

ID	Term
D000093542	Gemcitabine
D000077157	Sorafenib
D000073893	Sugars
D000069287	Capecitabine

Ancestor Terms

ID	Term
D006571	Heterocyclic Compounds
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D010671	Phenylurea Compounds
D014508	Urea
D000577	Amides
D009930	Organic Chemicals
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009536	Niacinamide
D009539	Nicotinic Acids
D000147	Acids, Heterocyclic
D011725	Pyridines
D002241	Carbohydrates
D005472	Fluorouracil
D014498	Uracil
D011744	Pyrimidinones
D003853	Deoxyribonucleosides
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases