Skip to content
← Full study record

NCT02574455 · OUTCOME

Percentage of Participants Experiencing the Worst Laboratory Abnormalities Grade 3 or 4 Post-Baseline

Trial of Sacituzumab Govitecan in Participants With Refractory/Relapsed Metastatic Triple-Negative Breast Cancer (TNBC) · Source last updated 2022-06-15

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
First dose date up to last follow-up (maximum up to 30.8 months)

What was measured

Blood samples were collected for hematology, serum chemistry and the laboratory abnormalities were assessed. The most severe graded abnormality observed post-baseline for each graded test was counted for each participant. Safety as assessed by grading of laboratory values and AEs according to the National Cancer Institutes' Common Terminology Criteria for Adverse Events (NCI CTCAE) covering grades 0-5 (0=Normal, 1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening, 5=Death). The percentage of participants with worst postbaseline grades 3 or 4 are reported.

Analysis population: Participants in the Safety analysis set were analyzed.

Groups in this outcome

Sacituzumab Govitecan

Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion either by gravity or with an infusion pump on Days 1 and 8 of a 21-day treatment cycle for up to 29.6 months. Infusion rate for the first 15 minutes started with 50 mg/hour or less with a subsequent infusion of 100 to 200 mg/hour up to a maximum recommended rate (advanced every 15 to 30 minutes) of 500 mg/hour with a subsequent infusion of 1000 mg/hour. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs.

Treatment of Physician's Choice (TPC)

Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent regimen that was selected by the investigator before participant randomization. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs. Eribulin was administered IV over 2 to 5 minutes at a dose 1.4 mg/m\^2 at North American sites and 1.23 mg/m\^2 at European sites on Days 1 and 8 of a 21-day cycle for up to 15.3 months. Lower doses were administered on the same schedule to participants with moderate hepatic impairment (ie, Child-Pugh B; 0.7 mg/m\^2 and 0.67 mg/m\^2 for North American and European sites, respectively). Capecitabine 1000 to 1250 mg/m\^2 was administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period for up to 10.6 months. Gemcitabine 800 to 1200 mg/m\^2 was administered IV over 30 minutes on Days 1, 8, and 15 of a 28-day cycle for up to 8.1 months. Vinorelbine 25 mg/m\^2 was administered as a weekly IV injection over 6-10 minutes for up to 11.5 months. Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Sacituzumab Govitecan258
Treatment of Physician's Choice (TPC)224

Reported measurements

Anemia
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sacituzumab Govitecan8.9Not reportedNot reportedNot reportedNot reported
Treatment of Physician's Choice (TPC)5.4Not reportedNot reportedNot reportedNot reported
Lymphocyte Count Decreased
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sacituzumab Govitecan33.3Not reportedNot reportedNot reportedNot reported
Treatment of Physician's Choice (TPC)25.0Not reportedNot reportedNot reportedNot reported
Neutrophil Count Decreased
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sacituzumab Govitecan48.8Not reportedNot reportedNot reportedNot reported
Treatment of Physician's Choice (TPC)35.3Not reportedNot reportedNot reportedNot reported
Platelet Count Decreased
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sacituzumab Govitecan1.2Not reportedNot reportedNot reportedNot reported
Treatment of Physician's Choice (TPC)2.7Not reportedNot reportedNot reportedNot reported
White Blood Cell Decreased
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sacituzumab Govitecan41.1Not reportedNot reportedNot reportedNot reported
Treatment of Physician's Choice (TPC)25.4Not reportedNot reportedNot reportedNot reported
Alanine Aminotransferase Increased
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sacituzumab Govitecan1.2Not reportedNot reportedNot reportedNot reported
Treatment of Physician's Choice (TPC)2.2Not reportedNot reportedNot reportedNot reported
Alkaline Phosphatase Increased
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sacituzumab Govitecan3.1Not reportedNot reportedNot reportedNot reported
Treatment of Physician's Choice (TPC)3.6Not reportedNot reportedNot reportedNot reported
Aspartate Aminotransferase Increased
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sacituzumab Govitecan3.5Not reportedNot reportedNot reportedNot reported
Treatment of Physician's Choice (TPC)2.2Not reportedNot reportedNot reportedNot reported
Blood Bilirubin Increased
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sacituzumab Govitecan1.9Not reportedNot reportedNot reportedNot reported
Treatment of Physician's Choice (TPC)2.7Not reportedNot reportedNot reportedNot reported
Creatinine Increased
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sacituzumab Govitecan0.4Not reportedNot reportedNot reportedNot reported
Treatment of Physician's Choice (TPC)0Not reportedNot reportedNot reportedNot reported
Hypercalcemia
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sacituzumab Govitecan0Not reportedNot reportedNot reportedNot reported
Treatment of Physician's Choice (TPC)0.4Not reportedNot reportedNot reportedNot reported
Hyperglycemia
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sacituzumab Govitecan3.1Not reportedNot reportedNot reportedNot reported
Treatment of Physician's Choice (TPC)3.1Not reportedNot reportedNot reportedNot reported
Hyperkalemia
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sacituzumab Govitecan0.8Not reportedNot reportedNot reportedNot reported
Treatment of Physician's Choice (TPC)0Not reportedNot reportedNot reportedNot reported
Hypermagnesemia
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sacituzumab Govitecan0.4Not reportedNot reportedNot reportedNot reported
Treatment of Physician's Choice (TPC)0.4Not reportedNot reportedNot reportedNot reported
Hypernatremia
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sacituzumab Govitecan0Not reportedNot reportedNot reportedNot reported
Treatment of Physician's Choice (TPC)0Not reportedNot reportedNot reportedNot reported
Hypoalbumenemia
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sacituzumab Govitecan0.8Not reportedNot reportedNot reportedNot reported
Treatment of Physician's Choice (TPC)1.3Not reportedNot reportedNot reportedNot reported
Hypocalcemia
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sacituzumab Govitecan1.6Not reportedNot reportedNot reportedNot reported
Treatment of Physician's Choice (TPC)1.3Not reportedNot reportedNot reportedNot reported
Hypoglycemia
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sacituzumab Govitecan0.4Not reportedNot reportedNot reportedNot reported
Treatment of Physician's Choice (TPC)0Not reportedNot reportedNot reportedNot reported
Hypokalemia
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sacituzumab Govitecan4.3Not reportedNot reportedNot reportedNot reported
Treatment of Physician's Choice (TPC)0.9Not reportedNot reportedNot reportedNot reported
Hypomagnesemia
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sacituzumab Govitecan0.8Not reportedNot reportedNot reportedNot reported
Treatment of Physician's Choice (TPC)0Not reportedNot reportedNot reportedNot reported
Hyponatremia
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sacituzumab Govitecan3.9Not reportedNot reportedNot reportedNot reported
Treatment of Physician's Choice (TPC)3.6Not reportedNot reportedNot reportedNot reported
Hypophosphatemia
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Sacituzumab Govitecan8.1Not reportedNot reportedNot reportedNot reported
Treatment of Physician's Choice (TPC)3.6Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        8.9
      2. group Id
        OG001
        value
        5.4
    title
    Anemia
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        33.3
      2. group Id
        OG001
        value
        25.0
    title
    Lymphocyte Count Decreased
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        48.8
      2. group Id
        OG001
        value
        35.3
    title
    Neutrophil Count Decreased
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1.2
      2. group Id
        OG001
        value
        2.7
    title
    Platelet Count Decreased
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        41.1
      2. group Id
        OG001
        value
        25.4
    title
    White Blood Cell Decreased
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1.2
      2. group Id
        OG001
        value
        2.2
    title
    Alanine Aminotransferase Increased
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        3.1
      2. group Id
        OG001
        value
        3.6
    title
    Alkaline Phosphatase Increased
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        3.5
      2. group Id
        OG001
        value
        2.2
    title
    Aspartate Aminotransferase Increased
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        1.9
      2. group Id
        OG001
        value
        2.7
    title
    Blood Bilirubin Increased
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        0.4
      2. group Id
        OG001
        value
        0
    title
    Creatinine Increased
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0.4
    title
    Hypercalcemia
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        3.1
      2. group Id
        OG001
        value
        3.1
    title
    Hyperglycemia
denoms
  1. counts
    1. group Id
      OG000
      value
      258
    2. group Id
      OG001
      value
      224
    units
    Participants
description
Blood samples were collected for hematology, serum chemistry and the laboratory abnormalities were assessed. The most severe graded abnormality observed post-baseline for each graded test was counted for each participant. Safety as assessed by grading of laboratory values and AEs according to the National Cancer Institutes' Common Terminology Criteria for Adverse Events (NCI CTCAE) covering grades 0-5 (0=Normal, 1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening, 5=Death). The percentage of participants with worst postbaseline grades 3 or 4 are reported.
groups
  1. description
    Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion either by gravity or with an infusion pump on Days 1 and 8 of a 21-day treatment cycle for up to 29.6 months. Infusion rate for the first 15 minutes started with 50 mg/hour or less with a subsequent infusion of 100 to 200 mg/hour up to a maximum recommended rate (advanced every 15 to 30 minutes) of 500 mg/hour with a subsequent infusion of 1000 mg/hour. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs.
    id
    OG000
    title
    Sacituzumab Govitecan
  2. description
    Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent regimen that was selected by the investigator before participant randomization. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs. Eribulin was administered IV over 2 to 5 minutes at a dose 1.4 mg/m\^2 at North American sites and 1.23 mg/m\^2 at European sites on Days 1 and 8 of a 21-day cycle for up to 15.3 months. Lower doses were administered on the same schedule to participants with moderate hepatic impairment (ie, Child-Pugh B; 0.7 mg/m\^2 and 0.67 mg/m\^2 for North American and European sites, respectively). Capecitabine 1000 to 1250 mg/m\^2 was administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period for up to 10.6 months. Gemcitabine 800 to 1200 mg/m\^2 was administered IV over 30 minutes on Days 1, 8, and 15 of a 28-day cycle for up to 8.1 months. Vinorelbine 25 mg/m\^2 was administered as a weekly IV injection over 6-10 minutes for up to 11.5 months. Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy.
    id
    OG001
    title
    Treatment of Physician's Choice (TPC)
param Type
NUMBER
population Description
Participants in the Safety analysis set were analyzed.
reporting Status
POSTED
time Frame
First dose date up to last follow-up (maximum up to 30.8 months)
title
Percentage of Participants Experiencing the Worst Laboratory Abnormalities Grade 3 or 4 Post-Baseline
type
SECONDARY
unit Of Measure
percentage of participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice