NCT02000622 · OUTCOME

Time to Second Subsequent Cancer Therapy or Death (TSST) at Extended OS

Assessment of the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations. · Source last updated 2026-02-13

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

Measure: MEDIAN
Unit: Months
Interval / dispersion: 95% Confidence Interval
Time frame: Subsequent cancer therapy status reviewed every 8 weeks following study treatment discontinuation until Sep 2017 (final OS DCO), then every 3 months. Assessed up to a maximum of 64 months.

What was measured

Time from randomisation to the earliest of second subsequent cancer therapy start date following study treatment discontinuation, or death.

Analysis population: Full Analysis Set (FAS) consisting of all randomised patients

Groups in this outcome

Olaparib 300 mg bd

Olaparib 300 mg bd tablets

Chemotherapy

Physician's choice of chemotherapy; capecitabine, vinorelbine, or eribulin

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

Analysis denominator · Participants

Group	Source count
Olaparib 300 mg bd	205
Chemotherapy	97

Reported measurements

Source class 1

Values in Months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Olaparib 300 mg bd	14.3	Not reported	12.3	15.7	Not reported
Chemotherapy	10.5	Not reported	8.5	11.3	Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

ci Lower Limit
0.40
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.72
estimate Comment
Hazard ratio \<1 favours olaparib.
group Description
Supportive analysis to PFS2.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
<0.0001
param Type
Hazard Ratio (HR)
param Value
0.54
statistical Comment
Stratified by received prior chemotherapy for metastatic breast cancer (yes/no) and receptor status.
statistical Method
Log Rank

Complete source fields

analyses

ci Lower Limit
0.40
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.72
estimate Comment
Hazard ratio \<1 favours olaparib.
group Description
Supportive analysis to PFS2.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
<0.0001
param Type
Hazard Ratio (HR)
param Value
0.54
statistical Comment
Stratified by received prior chemotherapy for metastatic breast cancer (yes/no) and receptor status.
statistical Method
Log Rank

classes

categories
measurements
group Id
OG000
lower Limit
12.3
upper Limit
15.7
value
14.3
group Id
OG001
lower Limit
8.5
upper Limit
11.3
value
10.5

denoms

counts
group Id
OG000
value
205
group Id
OG001
value
97
units
Participants

description

Time from randomisation to the earliest of second subsequent cancer therapy start date following study treatment discontinuation, or death.

dispersion Type

95% Confidence Interval

groups

description
Olaparib 300 mg bd tablets
id
OG000
title
Olaparib 300 mg bd
description
Physician's choice of chemotherapy; capecitabine, vinorelbine, or eribulin
id
OG001
title
Chemotherapy

param Type

MEDIAN

population Description

Full Analysis Set (FAS) consisting of all randomised patients

reporting Status

POSTED

time Frame

Subsequent cancer therapy status reviewed every 8 weeks following study treatment discontinuation until Sep 2017 (final OS DCO), then every 3 months. Assessed up to a maximum of 64 months.

title

Time to Second Subsequent Cancer Therapy or Death (TSST) at Extended OS

type

OTHER_PRE_SPECIFIED

unit Of Measure

Months

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

Preserved source evidence · Not medical advice