Trial Outcomes & Findings for Early Surgery or Standard Palliative Therapy in Treating Patients With Stage IV Breast Cancer (NCT NCT01242800)

Last Updated: 2023-06-29

Results Overview

Overall survival (OS) was defined as time from randomization to death from any cause. All patients will be followed for survival through 5 years. Cases with incomplete follow-up or without record of vital status will be censored at the date of last contact. 3-year OS rate was estimated using Kaplan-Meier method.

Recruitment status

COMPLETED

Study phase

Target enrollment

390 participants

Primary outcome timeframe

Assessed at baseline, then every 3 months within 2 years and every 6 months between 2-5 years, up to 5 years

Results posted on

2023-06-29

Participant Flow

This study was activated on February 8, 2011, accrued its first patient on May 16, 2011, and accrual was terminated on July 23, 2015 with a final accrual of 390 patients on Step 1. Of the 390 patients enrolled, 256 of them were randomized to Step 2 to arm I and arm II.

Participant milestones

Participant milestones
Measure	Arm I (Continued Systemic Therapy) Patients receive standard palliative therapy, if needed, to address symptoms such as tumor ulceration, pain, bulky adenopathy causing arm symptoms, and other similar situations. Therapy may consist of radiotherapy alone, surgery alone, or a combination of both. palliative surgery: Undergo standard palliative surgery palliative radiation therapy: Undergo standard palliative radiotherapy	Arm II (Early Local Therapy) Patients undergo surgery comprising breast-conserving therapy (BCT) or total mastectomy according to patient and treating physician preference. Surgery is to occur no later than 10 weeks after completion of 32 weeks of systemic therapy. Free surgical margins must be achieved with re-excision or mastectomy for patients undergoing BCT. After completion of BCT, patients undergo radiotherapy once a day, 5 days per week. Patients who had mastectomy undergo radiotherapy at the discretion of treating physician. therapeutic conventional surgery: Undergo early surgery radiation therapy: Undergo radiotherapy
Overall Study STARTED	131	125
Overall Study COMPLETED	131	106
Overall Study NOT COMPLETED	0	19

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm I (Continued Systemic Therapy) Patients receive standard palliative therapy, if needed, to address symptoms such as tumor ulceration, pain, bulky adenopathy causing arm symptoms, and other similar situations. Therapy may consist of radiotherapy alone, surgery alone, or a combination of both. palliative surgery: Undergo standard palliative surgery palliative radiation therapy: Undergo standard palliative radiotherapy	Arm II (Early Local Therapy) Patients undergo surgery comprising breast-conserving therapy (BCT) or total mastectomy according to patient and treating physician preference. Surgery is to occur no later than 10 weeks after completion of 32 weeks of systemic therapy. Free surgical margins must be achieved with re-excision or mastectomy for patients undergoing BCT. After completion of BCT, patients undergo radiotherapy once a day, 5 days per week. Patients who had mastectomy undergo radiotherapy at the discretion of treating physician. therapeutic conventional surgery: Undergo early surgery radiation therapy: Undergo radiotherapy
Overall Study Patient refusal	0	10
Overall Study Physician Decision	0	1
Overall Study Disease progression	0	3
Overall Study Lack of insurance coverage for surgery	0	1
Overall Study Reasons not reported	0	4

Baseline Characteristics

Early Surgery or Standard Palliative Therapy in Treating Patients With Stage IV Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I (Continued Systemic Therapy) n=131 Participants Patients receive standard palliative therapy, if needed, to address symptoms such as tumor ulceration, pain, bulky adenopathy causing arm symptoms, and other similar situations. Therapy may consist of radiotherapy alone, surgery alone, or a combination of both. palliative surgery: Undergo standard palliative surgery palliative radiation therapy: Undergo standard palliative radiotherapy	Arm II (Early Local Therapy) n=125 Participants Patients undergo surgery comprising breast-conserving therapy (BCT) or total mastectomy according to patient and treating physician preference. Surgery is to occur no later than 10 weeks after completion of 32 weeks of systemic therapy. Free surgical margins must be achieved with re-excision or mastectomy for patients undergoing BCT. After completion of BCT, patients undergo radiotherapy once a day, 5 days per week. Patients who had mastectomy undergo radiotherapy at the discretion of treating physician. therapeutic conventional surgery: Undergo early surgery radiation therapy: Undergo radiotherapy	Total n=256 Participants Total of all reporting groups
Age, Continuous	56 years n=93 Participants	55 years n=4 Participants	56 years n=27 Participants
Sex: Female, Male Female	131 Participants n=93 Participants	125 Participants n=4 Participants	256 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Black or African American	19 Participants n=93 Participants	19 Participants n=4 Participants	38 Participants n=27 Participants
Race (NIH/OMB) White	102 Participants n=93 Participants	98 Participants n=4 Participants	200 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=93 Participants	6 Participants n=4 Participants	13 Participants n=27 Participants

PRIMARY outcome

Timeframe: Assessed at baseline, then every 3 months within 2 years and every 6 months between 2-5 years, up to 5 years

Population: All randomized patients at step 2

Outcome measures

Outcome measures
Measure	Arm I (Continued Systemic Therapy) n=131 Participants Patients receive standard palliative therapy, if needed, to address symptoms such as tumor ulceration, pain, bulky adenopathy causing arm symptoms, and other similar situations. Therapy may consist of radiotherapy alone, surgery alone, or a combination of both. palliative surgery: Undergo standard palliative surgery palliative radiation therapy: Undergo standard palliative radiotherapy	Arm II (Early Local Therapy) n=125 Participants Patients undergo surgery comprising breast-conserving therapy (BCT) or total mastectomy according to patient and treating physician preference. Surgery is to occur no later than 10 weeks after completion of 32 weeks of systemic therapy. Free surgical margins must be achieved with re-excision or mastectomy for patients undergoing BCT. After completion of BCT, patients undergo radiotherapy once a day, 5 days per week. Patients who had mastectomy undergo radiotherapy at the discretion of treating physician. therapeutic conventional surgery: Undergo early surgery radiation therapy: Undergo radiotherapy
3-year Overall Survival Rate	67.9 percentage of participants Interval 58.8 to 75.5	68.4 percentage of participants Interval 59.0 to 76.1

SECONDARY outcome

Timeframe: Assessed at baseline, then every 3 months within 2 years and every 6 months between 2-5 years, up to 5 years

Population: All randomized patients at step 2

For patients in arm II (early local therapy), time to locoregional recurrence was defined as time from randomization to date of locoregional recurrence; for patients in arm A (continued systemic therapy), time to locoregional progression was defined as time from randomization to date of locoregional progression. In this study, locoregional recurrence was defined as the new development or clinically significant increase in size of any supraclavicular, infraclavicular, internal mammary or axillary adenopathy or chest wall disease or invasive in-breast recurrence for patients on arm B; for patients on arm A, locoregional progression was defined as the development of symptoms leading to a decision for local therapy. Locoregional recurrence/progression and distant progression were followed separately in the study, and the occurrence of one did not preclude the other getting reported. 3-year cumulative incidence of locoregional recurrence/progression was estimated.

Outcome measures

Outcome measures
Measure	Arm I (Continued Systemic Therapy) n=131 Participants Patients receive standard palliative therapy, if needed, to address symptoms such as tumor ulceration, pain, bulky adenopathy causing arm symptoms, and other similar situations. Therapy may consist of radiotherapy alone, surgery alone, or a combination of both. palliative surgery: Undergo standard palliative surgery palliative radiation therapy: Undergo standard palliative radiotherapy	Arm II (Early Local Therapy) n=125 Participants Patients undergo surgery comprising breast-conserving therapy (BCT) or total mastectomy according to patient and treating physician preference. Surgery is to occur no later than 10 weeks after completion of 32 weeks of systemic therapy. Free surgical margins must be achieved with re-excision or mastectomy for patients undergoing BCT. After completion of BCT, patients undergo radiotherapy once a day, 5 days per week. Patients who had mastectomy undergo radiotherapy at the discretion of treating physician. therapeutic conventional surgery: Undergo early surgery radiation therapy: Undergo radiotherapy
3-year Cumulative Incidence of Locoregional Recurrence/Progression	16.3 percentage of participants Interval 10.7 to 24.4	39.8 percentage of participants Interval 31.8 to 49.1

SECONDARY outcome

Timeframe: Assessed at 18 months after randomization

Population: All randomized patients at step 2 who reported quality of life data at 18 months after randomization

The Functional Assessment of Cancer Therapy-Breast Trial Outcome Index (FACT-B TOI) was used as the primary HRQL endpoint, measured by the prorated aggregate score of the 24 items from the FACT-B (7 functional well-being, 7 physical well-being, 10 breast cancer specific items). The theoretical range of the prorated aggregate score was 0-96, higher scores indicate better quality of life.

Outcome measures

Outcome measures
Measure	Arm I (Continued Systemic Therapy) n=65 Participants Patients receive standard palliative therapy, if needed, to address symptoms such as tumor ulceration, pain, bulky adenopathy causing arm symptoms, and other similar situations. Therapy may consist of radiotherapy alone, surgery alone, or a combination of both. palliative surgery: Undergo standard palliative surgery palliative radiation therapy: Undergo standard palliative radiotherapy	Arm II (Early Local Therapy) n=66 Participants Patients undergo surgery comprising breast-conserving therapy (BCT) or total mastectomy according to patient and treating physician preference. Surgery is to occur no later than 10 weeks after completion of 32 weeks of systemic therapy. Free surgical margins must be achieved with re-excision or mastectomy for patients undergoing BCT. After completion of BCT, patients undergo radiotherapy once a day, 5 days per week. Patients who had mastectomy undergo radiotherapy at the discretion of treating physician. therapeutic conventional surgery: Undergo early surgery radiation therapy: Undergo radiotherapy
Health-related Quality of Life (HRQL)	74.2 score on a scale Standard Deviation 11.5	68.0 score on a scale Standard Deviation 13.7

Adverse Events

Arm I (Continued Systemic Therapy)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 63 deaths

Arm II (Early Local Therapy)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 58 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Study Statistician

ECOG-ACRIN Cancer Research Group

Phone: 16176323012

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60