Breast Cancer
Conditions
Keywords
metastatic, secondary, Hormone Receptor-Positive Breast Cancer
Brief summary
This study will determine if hormone receptor positive premenopausal metastatic breast cancer patients who undergo removal of the ovaries in mid-luteal versus mid-follicular phase have a longer survival.
Detailed description
Rationale: Previous research suggests that women who have their ovaries removed as part of their treatment for breast cancer may live longer if the ovarian surgery is performed during the luteal phase (last 14 days of the menstrual cycle) rather than the follicular phase (the first 14 days of the menstrual cycle). The current study will evaluate this important research question in premenopausal women with metastatic hormone receptor-positive breast cancer who will be treated with surgery and tamoxifen. Purpose: The purpose of this research is to find out if premenopausal women with breast cancer that has spread to other parts of the body live longer if their ovaries are removed during the second half of the menstrual cycle. This study will compare how long women live if they have their ovaries removed during the first half of their menstrual cycle (follicular phase) to how long women live if they have their ovaries removed during the second half of their menstrual cycle (luteal phase). Tamoxifen will also be given to study participants. Treatment: Study participants will have tests performed in advance of surgery to remove their ovaries. Surgery will be performed within four weeks of these tests. The exact day will be determined by the study participant's menstrual history and by a process called randomization, which is a random decision making process to determine if each study participant will have their surgery during the first or second half of their menstrual cycle. On the day of surgery, blood will be taken immediately prior to surgery and three hours after surgery for hormone tests. After the surgery, study participants will be given tamoxifen in oral pills for daily consumption. Study participants will be asked to return to the hospital every two months for tests and distribution of additional tamoxifen tablets. Treatments will be discontinued for disease progression or unacceptable adverse effects.
Interventions
PROCEDUREoophorectomy
Excision of an ovary
DRUGTamoxifen
20 mg orally every day
Sponsors
Breast Cancer Research Foundation
International Breast Cancer Research Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Estrogen receptor or progesterone receptor positive breast cancer * Premenopausal with regular menstrual cycles
Exclusion criteria
* Current oral contraceptives
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | Up to 9 years | Assess whether patients who undergo surgical oophorectomy in the history-estimated mid-luteal phase of their menstrual cycles survive longer than patients who undergo this surgery in the history-estimated mid-follicular phase of their menstrual cycles. |
Countries
Bangladesh, China, India, Indonesia, Malaysia, Morocco, Nigeria, Philippines, United States, Vietnam
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| A Mid-luteal Surgery | 115 |
| B Mid-follicular Surgery | 119 |
| Total | 234 |
Baseline characteristics
| Characteristic | B Mid-follicular Surgery | A Mid-luteal Surgery | Total |
|---|---|---|---|
| Age, Continuous | 38.6 years STANDARD_DEVIATION 5.7 | 39.0 years STANDARD_DEVIATION 5.4 | 38.8 years STANDARD_DEVIATION 5.6 |
| Dominant metastatic site Bone | 25 participants | 20 participants | 45 participants |
| Dominant metastatic site Soft tissue | 83 participants | 76 participants | 159 participants |
| Dominant metastatic site Viscera | 11 participants | 19 participants | 30 participants |
| Region of Enrollment Bangladesh | 48 participants | 50 participants | 98 participants |
| Region of Enrollment China | 27 participants | 21 participants | 48 participants |
| Region of Enrollment Indonesia | 4 participants | 3 participants | 7 participants |
| Region of Enrollment Malaysia | 3 participants | 3 participants | 6 participants |
| Region of Enrollment Morocco | 1 participants | 0 participants | 1 participants |
| Region of Enrollment Nigeria | 6 participants | 6 participants | 12 participants |
| Region of Enrollment Philippines | 26 participants | 28 participants | 54 participants |
| Region of Enrollment Taiwan | 4 participants | 3 participants | 7 participants |
| Region of Enrollment Vietnam | 0 participants | 1 participants | 1 participants |
| Sex: Female, Male Female | 119 Participants | 115 Participants | 234 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 115 | 0 / 119 |
| serious Total, serious adverse events | 0 / 115 | 1 / 119 |
Outcome results
Primary
Overall Survival
Assess whether patients who undergo surgical oophorectomy in the history-estimated mid-luteal phase of their menstrual cycles survive longer than patients who undergo this surgery in the history-estimated mid-follicular phase of their menstrual cycles.
Time frame: Up to 9 years
Population: Analyzed all patients with followup data
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| A Mid-luteal Surgery | Overall Survival | 2.14 years |
| B Mid-follicular Surgery | Overall Survival | 2.00 years |