Participant flow

Early Surgery or Standard Palliative Therapy in Treating Patients With Stage IV Breast Cancer · Source last updated 2023-06-29

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

groups

1. description

   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

   id

   FG000

   title

   Arm I (Continued Systemic Therapy)

2. description

   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

   id

   FG001

   title

   Arm II (Early Local Therapy)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         10

      type

      Patient refusal

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Physician Decision

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         3

      type

      Disease progression

   4. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Lack of insurance coverage for surgery

   5. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         4

      type

      Reasons not reported

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         131

      2. group Id

         FG001

         num Subjects

         125

      type

      STARTED

   2. achievements

      1. comment

         Patient continued their systemic therapy after randomization per their treating physician's discretion.

         group Id

         FG000

         num Subjects

         131

      2. comment

         Protocol therapy was early surgery and/or radiation therapy in this trial.

         group Id

         FG001

         num Subjects

         106

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         19

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

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.

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Preserved source evidence · Not medical advice