Your session is about to expire
← Back to Search
Chemotherapy or Endocrine Therapy
Aggressive Local Therapy for Breast Cancer
Phase 2
Waitlist Available
Led By Eric A. Strom, MD, BS
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Breast cancer with metastasis to skeletal sites only
KPS greater than or equals to 70
Must not have
Prior radiation to site(s) of distant metastasis of bone
Distant metastasis to organs (local recurrence and regional lymph node recurrence are not considered as distant metastasis) other than bone
Timeline
Screening 3 weeks
Treatment Varies
Follow Up study assessment at 9 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing if adding surgery or radiation to standard chemotherapy or hormone therapy can help control metastatic breast cancer for a longer time.
Who is the study for?
This trial is for breast cancer patients with 1 to 3 bone-only metastatic sites, good physical functioning (KPS >=70), and normal organ function tests. It's open to those who've had prior chemotherapy but not for those with a risk of fracture needing immediate local therapy, other cancers within the last 3 years, or untreated central nervous system disorders.
What is being tested?
Researchers are testing if adding local treatments like surgery or radiation to standard therapies such as chemotherapy or endocrine therapy can extend the time without disease progression in patients with limited bone-only metastasis from breast cancer.
What are the potential side effects?
Potential side effects may include typical reactions from surgery and radiation like pain, swelling, infection risks at the treatment site, fatigue from chemotherapy or endocrine therapy, and possible complications related to underlying health conditions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer has spread only to my bones.
Select...
I am mostly able to care for myself and carry out daily activities.
Select...
I have had chemotherapy for my initial breast cancer.
Select...
My liver and kidney functions are within safe ranges.
Select...
I have 1 to 3 areas of cancer spread in my bones.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had radiation therapy for cancer that spread to my bones.
Select...
My cancer has spread to organs beyond the original site, excluding bones.
Select...
I have scleroderma or lupus, which makes radiation treatment riskier for me.
Select...
I am not medically fit for surgery due to serious health issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ study assessment at 9 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~study assessment at 9 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Patients with Progression-Free Survival (PFS)
Side effects data
From 2012 Phase 4 trial • 44 Patients • NCT0112933662%
Fatigue
31%
Back pain
28%
Nausea
24%
Arthralgia
21%
Blood creatinine increased
21%
Cough
17%
Bone pain
17%
Anaemia
17%
Neutropenia
17%
Dehydration
17%
Hot flush
17%
Vomiting
17%
Pyrexia
14%
Insomnia
14%
Dyspnoea
14%
Night sweats
14%
Decreased appetite
14%
Musculoskeletal pain
14%
Tachycardia
14%
Diarrhoea
14%
Chills
10%
Headache
10%
Hyponatraemia
10%
Hypocalcaemia
10%
Pain
10%
Upper respiratory tract infection
10%
Dizziness
10%
Pain in extremity
10%
Oedema peripheral
10%
Myalgia
10%
Neck pain
10%
Anxiety
10%
Depression
10%
Abdominal pain upper
10%
Haemoglobin decreased
10%
Hypotension
10%
Dry mouth
7%
Hypokalaemia
7%
Nail disorder
7%
Pulmonary embolism
7%
Thrombocytopenia
7%
Alanine aminotransferase increased
7%
Dry skin
7%
Epistaxis
7%
Neuropathy peripheral
7%
White blood cell count decreased
7%
Aspartate aminotransferase increased
7%
Hypoaesthesia
7%
Constipation
7%
Non-cardiac chest pain
7%
Peripheral sensory neuropathy
7%
Dysuria
7%
Alopecia
7%
Muscular weakness
7%
Oropharyngeal pain
7%
Abdominal pain
7%
Blood alkaline phosphatase increased
7%
Neutrophil count decreased
7%
Pleural effusion
7%
Pruritus
7%
Skin exfoliation
7%
Skin hyperpigmentation
7%
Dyspepsia
7%
Asthenia
7%
Oral herpes
7%
Weight decreased
3%
Urinary tract infection
3%
Dysgeusia
3%
Abdominal discomfort
3%
Dysphonia
3%
Loss of consciousness
3%
Joint swelling
3%
Musculoskeletal chest pain
3%
Altered state of consciousness
3%
Leukopenia
3%
Metastases to meninges
3%
Convulsion
3%
Mental status changes
3%
Renal failure
3%
Acute respiratory distress syndrome
3%
Hypoxia
3%
Abdominal distension
3%
Mucosal inflammation
3%
Palmar-plantar erythrodysaesthesia syndrome
3%
Rash
3%
Hypertension
3%
Chest discomfort
3%
Hepatic failure
3%
Extradural abscess
3%
Osteomyelitis
3%
Pharyngitis
3%
Pneumonia
3%
Sepsis
3%
Diabetes mellitus
3%
Hyperkalaemia
3%
Stomatitis
3%
Drug hypersensitivity
100%
80%
60%
40%
20%
0%
Study treatment Arm
Patients With Bone Metastases
Patients Without Bone Metastases
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Standard Therapy + Local TherapyExperimental Treatment2 Interventions
Systemic Standard Therapy (chemotherapy and/or endocrine therapy) + Local Therapy (surgery and/or radiation)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Local Therapy
2017
N/A
~30
Standard Therapy
2007
Completed Phase 4
~16800
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,066 Previous Clinical Trials
1,802,210 Total Patients Enrolled
146 Trials studying Breast Cancer
63,038 Patients Enrolled for Breast Cancer
Eric A. Strom, MD, BSPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My breast cancer has spread only to my bones.Your white blood cell count and platelet count are within a certain range.I may receive treatment for a high risk of fractures before starting systemic therapy.I may or may not have started taking bisphosphonates.I have used treatments for cancer spread to bones, fitting the study's treatment plan.I am mostly able to care for myself and carry out daily activities.I have had chemotherapy for my initial breast cancer.I have been cancer-free from a second type of cancer, except skin cancer, for less than 3 years.I am a woman who has not had a period for less than 12 months and will take a pregnancy test before joining the study.I have had radiation therapy for cancer that spread to my bones.My doctor believes my tumor can be safely treated with high-dose radiation.My cancer has spread to organs beyond the original site, excluding bones.I have scleroderma or lupus, which makes radiation treatment riskier for me.I am not medically fit for surgery due to serious health issues.My liver and kidney functions are within safe ranges.I have 1 to 3 areas of cancer spread in my bones.
Research Study Groups:
This trial has the following groups:- Group 1: Standard Therapy + Local Therapy
Awards:
This trial has 1 awards, including:- 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.
Other Trials to Consider
Popular Categories
Learn More About These Treatments
Share this study with friends
Copy Link
Messenger