Stage I Breast Cancer study: Endocrine Therapy
Official title De-Escalation of Breast Radiation Trial for Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score Less Than or Equal to 18 Breast Cancer (DEBRA)
ClinicalTrials.gov ID: NCT04852887
What this study is testing
What is Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane)?
An investigational hormone-blocking treatment being studied for stage I breast cancer. It is designed to block estrogen activity or reduce estrogen production to slow tumor growth.
Also referred to as Tamoxifen, Anastrozole, Letrozole, Exemestane.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether skipping radiation works as well as getting it. It looks at how often the cancer comes back in the same breast.
- Who it's for
- You may be able to join if you have early-stage breast cancer that responds to hormone therapy.
- What's involved
- You would have surgery to remove the tumor. You would also take hormone therapy. Some people would get radiation, while others would not.
- Time commitment
- The study lasts for a long time to see if the cancer comes back later.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 70
You may be able to join if
- The patient or a legally authorized representative must provide study-specific informed consent prior to pre-entry/Step 1 and, for patients treated...
- The patient must have an ECOG performance status of 0 or 1.
- The patient must have undergone a lumpectomy and the margins of the resected specimen or re-excision must be histologically free of invasive tumor...
- The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination.
- Patient must have undergone axillary staging (sentinel node biopsy and/or axillary node dissection).
You likely can't join if
- Definitive clinical or radiologic evidence of metastatic disease.
- pT1 mi and pT2 - pT4 tumors including inflammatory breast cancer.
- Pathologic staging of pN0(i+) or pN0(mol+), pN1, pN2, or pN3 disease.
- Patient had a mastectomy.
- Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes, unless...
- Suspicious microcalcifications, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be...
See the full eligibility criteria
Who can join
- The patient or a legally authorized representative must provide study-specific informed consent prior to pre-entry/Step 1 and, for patients treated in the U.S., authorization permitting release of personal health...
- The patient must have an ECOG performance status of 0 or 1.
- The patient must have undergone a lumpectomy and the margins of the resected specimen or re-excision must be histologically free of invasive tumor and DCIS with no ink on tumor as determined by the local pathologist.
- The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination.
- Patient must have undergone axillary staging (sentinel node biopsy and/or axillary node dissection).
- By pathologic evaluation, primary tumor must be pT1 (less than or equal to 2 cm).
- By pathologic evaluation, ipsilateral nodes must be pN0. (Patients with pathologic staging of pN0(i+) or pN0(mol+) are NOT eligible.)
- Oncotype DX Recurrence Score of less than or equal to 18 on diagnostic core biopsy or resected specimen.
- An Oncotype RS is required for eligibility, however, for a patient whose tumor has already had a MammaPrint test completed as part of usual care when being considered for enrollment and is in the binary "Low" category...
- The tumor must have been determined to be ER and/or PgR positive assessed by current ASCO/CAP Guideline Recommendations for hormone receptor testing.
- The tumor must have been determined to be HER2-negative by current ASCO/CAP guidelines.
- Age 56 or older with no spontaneous menses for at least 12 months prior to pre-entry/Step 1; or a documented hysterectomy; or
- Age 55 or younger with no spontaneous menses for at least 12 months prior to pre-entry/Step 1 (e.g., spontaneous or secondary to hysterectomy) and with a documented estradiol level in the postmenopausal range according...
- The interval between the last surgery for breast cancer (including re-excision of margins) and pre-entry/Step 1 must be no more than 70 days.
- The patient must have recovered from surgery with the incision completely healed and no signs of infection.
- Bilateral mammogram or MRI within 6 months prior to pre-entry/Step 1. HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
What rules you out
- Definitive clinical or radiologic evidence of metastatic disease.
- pT1 mi and pT2 - pT4 tumors including inflammatory breast cancer.
- Pathologic staging of pN0(i+) or pN0(mol+), pN1, pN2, or pN3 disease.
- Patient had a mastectomy.
- Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor.
- Suspicious microcalcifications, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign.
- Non-epithelial breast malignancies such as sarcoma or lymphoma.
- Proven multicentric carcinoma (invasive cancer or DCIS) in more than one quadrant or separated by 4 or more centimeters. (Patients with multifocal carcinoma are eligible.)
- Paget's disease of the nipple.
- Any history, not including the index cancer, of ipsilateral invasive breast cancer or ipsilateral DCIS treated or not treated. (Patients with synchronous or previous ipsilateral LCIS are eligible.)
- Synchronous or previous contralateral invasive breast cancer or DCIS. (Patients with synchronous and/or previous contralateral LCIS are eligible.)
- Surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation. (If surgical margins are rendered free of disease by re- excision, the patient is eligible.)
- Treatment plan that includes regional nodal irradiation.
- Any treatment with radiation therapy, chemotherapy, or biotherapy, administered for the currently diagnosed breast cancer prior to pre-entry/Step 1.
- History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to pre-entry/Step 1.
- the Oncotype DX Recurrence Score is assessed on the biopsy core and is less than or equal to 18, AND
- the patient had not initiated endocrine therapy prior to core biopsy tissue collection. \ \ \ This does not apply to adjuvant endocrine therapy recommended for this diagnosis which may start any time after surgery...
- Patients intending to continue on oral, transdermal, or subdermal estrogen replacement (including all estrogen only and estrogen-progesterone formulas) are not eligible.
- Prior breast or thoracic RT for any condition.
- Active collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma.
- Pregnancy or lactation at the time of pre-entry/Step 1 or intention to become pregnant during treatment.
- Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of study therapy or that may...
- Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements or interfere with interpretation of study results.
- Use of any investigational product within 30 days prior to pre-entry/Step 1.
The study team makes the final eligibility decision.
Where it is enrolling
- Mobile, Alabama, United States
- Kingman, Arizona, United States
- Phoenix, Arizona, United States
- Little Rock, Arkansas, United States
- Anaheim, California, United States
- Antioch, California, United States
- Arroyo Grande, California, United States
- Auburn, California, United States
- Bellflower, California, United States
- Berkeley, California, United States
- Carmichael, California, United States
- Dublin, California, United States
- Elk Grove, California, United States
- Fremont, California, United States
- Fresno, California, United States
- Irvine, California, United States
- Los Angeles, California, United States
- Modesto, California, United States
- Mountain View, California, United States
- Oakland, California, United States
+ 497 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Mobile, Alabama, United States; Kingman, Arizona, United States; Phoenix, Arizona, United States; Little Rock, Arkansas, United States; Anaheim, California, United States; Antioch, California, United States and 511 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.