Trial Outcomes & Findings for S0430 Cyclophosphamide and Capecitabine in Treating Women With Stage IV Breast Cancer (NCT NCT00107276)

Last Updated: 2013-07-18

Results Overview

Complete Response (CR) is complete disappearance of all measurable and non-measurable disease. No new lesions, no disease related symptoms. Normalization of markers and other abnormal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration. Progression is 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed and/or unequivocal progression of non-measurable disease and/or appearance of new lesion/site or death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

112 participants

Primary outcome timeframe

Patients assessed at least every six weeks while on protocol treatment

Results posted on

2013-07-18

Participant Flow

Between 8/15/2005 and 9/1/2007, 112 patients were registered from 26 SWOG institutions who obtained Institutional Review Board (IRB) approval for the study.

Participant milestones

Participant milestones
Measure	Cyclophosphamide and Capecitabine cyclophosphamide orally days 1-14 and capecitabine orally days 15-21 for 8 cycles of 21 days each
Overall Study STARTED	112
Overall Study Eligible	96
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	72

Reasons for withdrawal

Reasons for withdrawal
Measure	Cyclophosphamide and Capecitabine cyclophosphamide orally days 1-14 and capecitabine orally days 15-21 for 8 cycles of 21 days each
Overall Study Progression	46
Overall Study Adverse Event	6
Overall Study M.D. decision	2
Overall Study Patient refusal	1
Overall Study Death	1
Overall Study Ineligible	16

Baseline Characteristics

S0430 Cyclophosphamide and Capecitabine in Treating Women With Stage IV Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cyclophosphamide and Capecitabine n=96 Participants cyclophosphamide orally days 1-14 and capecitabine orally days 15-21 for 8 cycles of 21 days each
Age Continuous	59.7 years n=5 Participants
Sex: Female, Male Female	96 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Patients assessed at least every six weeks while on protocol treatment

Population: Eligible patients with RECIST measurable disease

Outcome measures

Outcome measures
Measure	Cyclophosphamide and Capecitabine n=80 Participants cyclophosphamide orally days 1-14 and capecitabine orally days 15-21 for 8 cycles of 21 days each
Response Rate (Complete and Partial, Confirmed and Unconfirmed)	29 participants

SECONDARY outcome

Timeframe: two years

Population: All eligible patients

Progression-Free Survival: From date of registration to time of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at last date of contact. Overall Survival: From date of registration to date of death due to any cause. Patients last known to be alive are censored at last date of contact. Progression is 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed and/or unequivocal progression of non-measurable disease and/or appearance of new lesion/site or death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.

Outcome measures

Outcome measures
Measure	Cyclophosphamide and Capecitabine n=96 Participants cyclophosphamide orally days 1-14 and capecitabine orally days 15-21 for 8 cycles of 21 days each
Progression-free Survival and Overall Survival PFS	5.9 months Interval 3.7 to 8.0
Progression-free Survival and Overall Survival OS	18.8 months Interval 13.1 to 22.0

SECONDARY outcome

Timeframe: Patients assessed after each 21-day cycle for 8 cycles (24 weeks of treatment)

Population: Eligible patients evaluable for toxicity assessment (one eligible patient who was removed from treatment due to disease progression less than 3 weeks after registration is not evaluable for toxicity assessment)

Number of patients for whom Grade 3 or higher toxicity observed during treatment. Only adverse events that are possibly, probably or definitely related to study drug are reported.

Outcome measures

Outcome measures
Measure	Cyclophosphamide and Capecitabine n=95 Participants cyclophosphamide orally days 1-14 and capecitabine orally days 15-21 for 8 cycles of 21 days each
Toxicity ALT, SGPT (serum glutamic pyruvic transaminase)	1 Participants
Toxicity Alkaline phosphatase	1 Participants
Toxicity Dehydration	2 Participants
Toxicity Diarrhea	2 Participants
Toxicity Dyspnea (shortness of breath)	1 Participants
Toxicity Fatigue (asthenia, lethargy, malaise)	2 Participants
Toxicity Febrile neutropenia	1 Participants
Toxicity Hemoglobin	1 Participants
Toxicity Leukocytes (total WBC)	15 Participants
Toxicity Lymphopenia	13 Participants
Toxicity Mood alteration - depression	1 Participants
Toxicity Nausea	1 Participants
Toxicity Neuroendocrine: ADH secretion abnormality	1 Participants
Toxicity Neutrophils/granulocytes (ANC/AGC)	7 Participants
Toxicity Platelets	1 Participants
Toxicity Potassium, serum-low (hypokalemia)	1 Participants
Toxicity Pruritus/itching	1 Participants
Toxicity Rash/desquamation	1 Participants
Toxicity Rash: hand-foot skin reaction	7 Participants
Toxicity Sodium, serum-low (hyponatremia)	1 Participants
Toxicity Thrombosis/thrombus/embolism	2 Participants
Toxicity Weight loss	1 Participants

Adverse Events

Cyclophosphamide and Capecitabine

Serious events: 4 serious events

Other events: 92 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cyclophosphamide and Capecitabine n=95 participants at risk
General disorders Death not associated with CTCAE term - Death NOS	1.1% 1/95 • Every 3 weeks for up to 2 years. Number "At Risk" includes all eligible patients evaluable for toxicity assessment (one eligible patient who was removed from treatment due to disease progression less than 3 weeks after registration is not evaluable for toxicity assessment)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Death - Disease progression NOS	2.1% 2/95 • Every 3 weeks for up to 2 years. Number "At Risk" includes all eligible patients evaluable for toxicity assessment (one eligible patient who was removed from treatment due to disease progression less than 3 weeks after registration is not evaluable for toxicity assessment)
Nervous system disorders CNS cerebrovascular ischemia	1.1% 1/95 • Every 3 weeks for up to 2 years. Number "At Risk" includes all eligible patients evaluable for toxicity assessment (one eligible patient who was removed from treatment due to disease progression less than 3 weeks after registration is not evaluable for toxicity assessment)

Other adverse events

Other adverse events
Measure	Cyclophosphamide and Capecitabine n=95 participants at risk
Blood and lymphatic system disorders Hemoglobin	42.1% 40/95 • Every 3 weeks for up to 2 years. Number "At Risk" includes all eligible patients evaluable for toxicity assessment (one eligible patient who was removed from treatment due to disease progression less than 3 weeks after registration is not evaluable for toxicity assessment)
Gastrointestinal disorders Constipation	16.8% 16/95 • Every 3 weeks for up to 2 years. Number "At Risk" includes all eligible patients evaluable for toxicity assessment (one eligible patient who was removed from treatment due to disease progression less than 3 weeks after registration is not evaluable for toxicity assessment)
Gastrointestinal disorders Diarrhea	33.7% 32/95 • Every 3 weeks for up to 2 years. Number "At Risk" includes all eligible patients evaluable for toxicity assessment (one eligible patient who was removed from treatment due to disease progression less than 3 weeks after registration is not evaluable for toxicity assessment)
Gastrointestinal disorders Heartburn/dyspepsia	10.5% 10/95 • Every 3 weeks for up to 2 years. Number "At Risk" includes all eligible patients evaluable for toxicity assessment (one eligible patient who was removed from treatment due to disease progression less than 3 weeks after registration is not evaluable for toxicity assessment)
Gastrointestinal disorders Mucositis/stomatitis (clinical exam) - Oral cavity	8.4% 8/95 • Every 3 weeks for up to 2 years. Number "At Risk" includes all eligible patients evaluable for toxicity assessment (one eligible patient who was removed from treatment due to disease progression less than 3 weeks after registration is not evaluable for toxicity assessment)
Gastrointestinal disorders Mucositis/stomatitis (functional/symp) - Oral cav	5.3% 5/95 • Every 3 weeks for up to 2 years. Number "At Risk" includes all eligible patients evaluable for toxicity assessment (one eligible patient who was removed from treatment due to disease progression less than 3 weeks after registration is not evaluable for toxicity assessment)
Gastrointestinal disorders Nausea	55.8% 53/95 • Every 3 weeks for up to 2 years. Number "At Risk" includes all eligible patients evaluable for toxicity assessment (one eligible patient who was removed from treatment due to disease progression less than 3 weeks after registration is not evaluable for toxicity assessment)
Gastrointestinal disorders Pain - Abdomen NOS	6.3% 6/95 • Every 3 weeks for up to 2 years. Number "At Risk" includes all eligible patients evaluable for toxicity assessment (one eligible patient who was removed from treatment due to disease progression less than 3 weeks after registration is not evaluable for toxicity assessment)
Gastrointestinal disorders Vomiting	29.5% 28/95 • Every 3 weeks for up to 2 years. Number "At Risk" includes all eligible patients evaluable for toxicity assessment (one eligible patient who was removed from treatment due to disease progression less than 3 weeks after registration is not evaluable for toxicity assessment)
General disorders Edema: limb	11.6% 11/95 • Every 3 weeks for up to 2 years. Number "At Risk" includes all eligible patients evaluable for toxicity assessment (one eligible patient who was removed from treatment due to disease progression less than 3 weeks after registration is not evaluable for toxicity assessment)
General disorders Fatigue (asthenia, lethargy, malaise)	64.2% 61/95 • Every 3 weeks for up to 2 years. Number "At Risk" includes all eligible patients evaluable for toxicity assessment (one eligible patient who was removed from treatment due to disease progression less than 3 weeks after registration is not evaluable for toxicity assessment)
General disorders Pain-Other (Specify)	10.5% 10/95 • Every 3 weeks for up to 2 years. Number "At Risk" includes all eligible patients evaluable for toxicity assessment (one eligible patient who was removed from treatment due to disease progression less than 3 weeks after registration is not evaluable for toxicity assessment)
Investigations ALT, SGPT (serum glutamic pyruvic transaminase)	12.6% 12/95 • Every 3 weeks for up to 2 years. Number "At Risk" includes all eligible patients evaluable for toxicity assessment (one eligible patient who was removed from treatment due to disease progression less than 3 weeks after registration is not evaluable for toxicity assessment)
Investigations AST, SGOT	18.9% 18/95 • Every 3 weeks for up to 2 years. Number "At Risk" includes all eligible patients evaluable for toxicity assessment (one eligible patient who was removed from treatment due to disease progression less than 3 weeks after registration is not evaluable for toxicity assessment)
Investigations Alkaline phosphatase	20.0% 19/95 • Every 3 weeks for up to 2 years. Number "At Risk" includes all eligible patients evaluable for toxicity assessment (one eligible patient who was removed from treatment due to disease progression less than 3 weeks after registration is not evaluable for toxicity assessment)
Investigations Bilirubin (hyperbilirubinemia)	11.6% 11/95 • Every 3 weeks for up to 2 years. Number "At Risk" includes all eligible patients evaluable for toxicity assessment (one eligible patient who was removed from treatment due to disease progression less than 3 weeks after registration is not evaluable for toxicity assessment)
Investigations Leukocytes (total WBC)	45.3% 43/95 • Every 3 weeks for up to 2 years. Number "At Risk" includes all eligible patients evaluable for toxicity assessment (one eligible patient who was removed from treatment due to disease progression less than 3 weeks after registration is not evaluable for toxicity assessment)
Investigations Lymphopenia	22.1% 21/95 • Every 3 weeks for up to 2 years. Number "At Risk" includes all eligible patients evaluable for toxicity assessment (one eligible patient who was removed from treatment due to disease progression less than 3 weeks after registration is not evaluable for toxicity assessment)
Investigations Neutrophils/granulocytes (ANC/AGC)	30.5% 29/95 • Every 3 weeks for up to 2 years. Number "At Risk" includes all eligible patients evaluable for toxicity assessment (one eligible patient who was removed from treatment due to disease progression less than 3 weeks after registration is not evaluable for toxicity assessment)
Investigations Platelets	13.7% 13/95 • Every 3 weeks for up to 2 years. Number "At Risk" includes all eligible patients evaluable for toxicity assessment (one eligible patient who was removed from treatment due to disease progression less than 3 weeks after registration is not evaluable for toxicity assessment)
Investigations Weight loss	8.4% 8/95 • Every 3 weeks for up to 2 years. Number "At Risk" includes all eligible patients evaluable for toxicity assessment (one eligible patient who was removed from treatment due to disease progression less than 3 weeks after registration is not evaluable for toxicity assessment)
Metabolism and nutrition disorders Albumin, serum-low (hypoalbuminemia)	5.3% 5/95 • Every 3 weeks for up to 2 years. Number "At Risk" includes all eligible patients evaluable for toxicity assessment (one eligible patient who was removed from treatment due to disease progression less than 3 weeks after registration is not evaluable for toxicity assessment)
Metabolism and nutrition disorders Anorexia	24.2% 23/95 • Every 3 weeks for up to 2 years. Number "At Risk" includes all eligible patients evaluable for toxicity assessment (one eligible patient who was removed from treatment due to disease progression less than 3 weeks after registration is not evaluable for toxicity assessment)
Metabolism and nutrition disorders Calcium, serum-low (hypocalcemia)	7.4% 7/95 • Every 3 weeks for up to 2 years. Number "At Risk" includes all eligible patients evaluable for toxicity assessment (one eligible patient who was removed from treatment due to disease progression less than 3 weeks after registration is not evaluable for toxicity assessment)
Metabolism and nutrition disorders Glucose, serum-high (hyperglycemia)	30.5% 29/95 • Every 3 weeks for up to 2 years. Number "At Risk" includes all eligible patients evaluable for toxicity assessment (one eligible patient who was removed from treatment due to disease progression less than 3 weeks after registration is not evaluable for toxicity assessment)
Metabolism and nutrition disorders Potassium, serum-low (hypokalemia)	8.4% 8/95 • Every 3 weeks for up to 2 years. Number "At Risk" includes all eligible patients evaluable for toxicity assessment (one eligible patient who was removed from treatment due to disease progression less than 3 weeks after registration is not evaluable for toxicity assessment)
Metabolism and nutrition disorders Sodium, serum-low (hyponatremia)	12.6% 12/95 • Every 3 weeks for up to 2 years. Number "At Risk" includes all eligible patients evaluable for toxicity assessment (one eligible patient who was removed from treatment due to disease progression less than 3 weeks after registration is not evaluable for toxicity assessment)
Musculoskeletal and connective tissue disorders Muscle weakness, not d/t neuropathy - body/general	5.3% 5/95 • Every 3 weeks for up to 2 years. Number "At Risk" includes all eligible patients evaluable for toxicity assessment (one eligible patient who was removed from treatment due to disease progression less than 3 weeks after registration is not evaluable for toxicity assessment)
Musculoskeletal and connective tissue disorders Pain - Back	10.5% 10/95 • Every 3 weeks for up to 2 years. Number "At Risk" includes all eligible patients evaluable for toxicity assessment (one eligible patient who was removed from treatment due to disease progression less than 3 weeks after registration is not evaluable for toxicity assessment)
Musculoskeletal and connective tissue disorders Pain - Bone	13.7% 13/95 • Every 3 weeks for up to 2 years. Number "At Risk" includes all eligible patients evaluable for toxicity assessment (one eligible patient who was removed from treatment due to disease progression less than 3 weeks after registration is not evaluable for toxicity assessment)
Musculoskeletal and connective tissue disorders Pain - Extremity-limb	8.4% 8/95 • Every 3 weeks for up to 2 years. Number "At Risk" includes all eligible patients evaluable for toxicity assessment (one eligible patient who was removed from treatment due to disease progression less than 3 weeks after registration is not evaluable for toxicity assessment)
Musculoskeletal and connective tissue disorders Pain - Joint	7.4% 7/95 • Every 3 weeks for up to 2 years. Number "At Risk" includes all eligible patients evaluable for toxicity assessment (one eligible patient who was removed from treatment due to disease progression less than 3 weeks after registration is not evaluable for toxicity assessment)
Nervous system disorders Dizziness	12.6% 12/95 • Every 3 weeks for up to 2 years. Number "At Risk" includes all eligible patients evaluable for toxicity assessment (one eligible patient who was removed from treatment due to disease progression less than 3 weeks after registration is not evaluable for toxicity assessment)
Nervous system disorders Neuropathy: sensory	14.7% 14/95 • Every 3 weeks for up to 2 years. Number "At Risk" includes all eligible patients evaluable for toxicity assessment (one eligible patient who was removed from treatment due to disease progression less than 3 weeks after registration is not evaluable for toxicity assessment)
Nervous system disorders Pain - Head/headache	8.4% 8/95 • Every 3 weeks for up to 2 years. Number "At Risk" includes all eligible patients evaluable for toxicity assessment (one eligible patient who was removed from treatment due to disease progression less than 3 weeks after registration is not evaluable for toxicity assessment)
Nervous system disorders Taste alteration (dysgeusia)	9.5% 9/95 • Every 3 weeks for up to 2 years. Number "At Risk" includes all eligible patients evaluable for toxicity assessment (one eligible patient who was removed from treatment due to disease progression less than 3 weeks after registration is not evaluable for toxicity assessment)
Psychiatric disorders Insomnia	6.3% 6/95 • Every 3 weeks for up to 2 years. Number "At Risk" includes all eligible patients evaluable for toxicity assessment (one eligible patient who was removed from treatment due to disease progression less than 3 weeks after registration is not evaluable for toxicity assessment)
Psychiatric disorders Mood alteration - anxiety	11.6% 11/95 • Every 3 weeks for up to 2 years. Number "At Risk" includes all eligible patients evaluable for toxicity assessment (one eligible patient who was removed from treatment due to disease progression less than 3 weeks after registration is not evaluable for toxicity assessment)
Psychiatric disorders Mood alteration - depression	15.8% 15/95 • Every 3 weeks for up to 2 years. Number "At Risk" includes all eligible patients evaluable for toxicity assessment (one eligible patient who was removed from treatment due to disease progression less than 3 weeks after registration is not evaluable for toxicity assessment)
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	8.4% 8/95 • Every 3 weeks for up to 2 years. Number "At Risk" includes all eligible patients evaluable for toxicity assessment (one eligible patient who was removed from treatment due to disease progression less than 3 weeks after registration is not evaluable for toxicity assessment)
Respiratory, thoracic and mediastinal disorders Cough	10.5% 10/95 • Every 3 weeks for up to 2 years. Number "At Risk" includes all eligible patients evaluable for toxicity assessment (one eligible patient who was removed from treatment due to disease progression less than 3 weeks after registration is not evaluable for toxicity assessment)
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	21.1% 20/95 • Every 3 weeks for up to 2 years. Number "At Risk" includes all eligible patients evaluable for toxicity assessment (one eligible patient who was removed from treatment due to disease progression less than 3 weeks after registration is not evaluable for toxicity assessment)
Skin and subcutaneous tissue disorders Dry skin	7.4% 7/95 • Every 3 weeks for up to 2 years. Number "At Risk" includes all eligible patients evaluable for toxicity assessment (one eligible patient who was removed from treatment due to disease progression less than 3 weeks after registration is not evaluable for toxicity assessment)
Skin and subcutaneous tissue disorders Hair loss/Alopecia (scalp or body)	5.3% 5/95 • Every 3 weeks for up to 2 years. Number "At Risk" includes all eligible patients evaluable for toxicity assessment (one eligible patient who was removed from treatment due to disease progression less than 3 weeks after registration is not evaluable for toxicity assessment)
Skin and subcutaneous tissue disorders Nail changes	7.4% 7/95 • Every 3 weeks for up to 2 years. Number "At Risk" includes all eligible patients evaluable for toxicity assessment (one eligible patient who was removed from treatment due to disease progression less than 3 weeks after registration is not evaluable for toxicity assessment)
Skin and subcutaneous tissue disorders Rash/desquamation	5.3% 5/95 • Every 3 weeks for up to 2 years. Number "At Risk" includes all eligible patients evaluable for toxicity assessment (one eligible patient who was removed from treatment due to disease progression less than 3 weeks after registration is not evaluable for toxicity assessment)
Skin and subcutaneous tissue disorders Rash: hand-foot skin reaction	38.9% 37/95 • Every 3 weeks for up to 2 years. Number "At Risk" includes all eligible patients evaluable for toxicity assessment (one eligible patient who was removed from treatment due to disease progression less than 3 weeks after registration is not evaluable for toxicity assessment)
Vascular disorders Hot flashes/flushes	7.4% 7/95 • Every 3 weeks for up to 2 years. Number "At Risk" includes all eligible patients evaluable for toxicity assessment (one eligible patient who was removed from treatment due to disease progression less than 3 weeks after registration is not evaluable for toxicity assessment)

Additional Information

Study statistician

SWOG

Phone: 206-667-4623

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place