Your session is about to expire
← Back to Search
Hormone Therapy
Hormone Therapy + Chemotherapy for Breast Cancer
Phase 3
Waitlist Available
Led By Kevin M Kalinsky
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have a histologically confirmed diagnosis of node positive (1-3 nodes) invasive breast carcinoma with positive estrogen and/or progesterone receptor status, and negative HER-2 status
Patients must have had either breast-conserving surgery with planned radiation therapy or total mastectomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months after randomization
Awards & highlights
Study Summary
This trial is testing 4 different hormone therapies with or without chemotherapy to see which is most effective in treating patients with invasive breast cancer.
Who is the study for?
This trial is for women aged 18+ who've had breast surgery and need radiation or mastectomy, with a performance status of 0-2. They must be able to receive certain chemotherapies, have node-positive invasive breast cancer that's estrogen/progesterone receptor positive and HER-2 negative. No recent other cancers (except some skin/cervical cancers) or chronic steroid/immunosuppressant use.Check my eligibility
What is being tested?
The study compares the effectiveness of hormone therapies (tamoxifen citrate, anastrozole, letrozole, exemestane) alone versus combined with chemotherapy in treating invasive breast cancer. It aims to see which combination better stops tumor growth by blocking estrogen or killing/dividing cells.See study design
What are the potential side effects?
Possible side effects include hot flashes, mood swings, joint pain from hormone therapy; nausea, hair loss, fatigue from chemotherapy. Each patient may experience side effects differently depending on their individual response to treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer is hormone receptor positive, HER2 negative, and has spread to 1-3 lymph nodes.
Select...
I had surgery for breast cancer and will have or had radiation.
Select...
I can take care of myself and am up and about more than 50% of my waking hours.
Select...
I am a woman and I am 18 years old or older.
Select...
I can receive chemotherapy that includes taxane or anthracycline.
Select...
I have had a procedure to check for cancer in my underarm lymph nodes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of randomization to a maximum of 5.5 years or death
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomization to a maximum of 5.5 years or death
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Invasive Disease-Free Survival (IDFS)
Secondary outcome measures
Distant Disease-Free Survival (DDFS)
Local Disease-Free Interval (LDFI)
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Arm II (endocrine therapy)Experimental Treatment6 Interventions
Patients receive a protocol-approved endocrine therapy comprising tamoxifen citrate, an aromatase inhibitor (anastrozole, letrozole, or exemestane), or both for 5-10 years in the absence of disease progression or unacceptable toxicity.
Group II: Arm I (chemotherapy and endocrine therapy)Experimental Treatment7 Interventions
Patients receive a protocol-approved chemotherapy regimen based on the patient and/or physician preference. Patients then receive a protocol-approved adjuvant endocrine therapy comprising tamoxifen citrate, an aromatase inhibitor (anastrozole, letrozole, or exemestane), or both for 5-10 years in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exemestane
2003
Completed Phase 4
~7880
Tamoxifen Citrate
2011
Completed Phase 3
~3750
Letrozole
2002
Completed Phase 4
~3240
Anastrozole
2019
Completed Phase 4
~10300
Systemic Chemotherapy
2011
N/A
~60
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,658 Previous Clinical Trials
40,919,471 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
Kevin M KalinskyPrincipal InvestigatorSWOG Cancer Research Network
1 Previous Clinical Trials
35 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My breast cancer is hormone receptor positive, HER2 negative, and has spread to 1-3 lymph nodes.I had surgery for breast cancer and will have or had radiation.I am not on long-term steroids or drugs that weaken my immune system.I can take care of myself and am up and about more than 50% of my waking hours.I am a woman and I am 18 years old or older.I can receive chemotherapy that includes taxane or anthracycline.I have not started any chemotherapy or hormone therapy for my breast cancer.I registered for Oncotype DX within 56 days after my surgery.I do not have inflammatory breast cancer or cancer that has spread.I have cancer in more than one area of my breasts.I have no cancer history except for certain skin cancers, cervical cancer in situ, or any cancer I've been free of for 5 years.I have had a procedure to check for cancer in my underarm lymph nodes.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (chemotherapy and endocrine therapy)
- Group 2: Arm II (endocrine therapy)
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the usual function of Tamoxifen Citrate?
"Tamoxifen Citrate is an effective treatment for ovarian cancer, as well as other malignant neoplasms."
Answered by AI
Could you share any other research that has been done on Tamoxifen Citrate?
"There are a total of 235 active clinical trials for Tamoxifen Citrate. Of these, 67 are classified as Phase 3 studies. 16108 different medical centres around the world are running these trials."
Answered by AI
Is Tamoxifen Citrate safe for human use?
"Tamoxifen citrate is considered safe based on data from prior clinical trials."
Answered by AI
Who else is applying?
What state do they live in?
North Carolina
How old are they?
18 - 65
What site did they apply to?
Maria Parham Hospital
Rex Cancer Center of Wakefield
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
Share this study with friends
Copy Link
Messenger