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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
Patients with immanent risk of fracture(s) may receive local therapy prior to systemic therapy. Otherwise systemic therapy should be given first as outlined in abstract treatment study plan sections 1 and 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up study assessment at 9 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
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I may receive treatment for a high risk of fractures before starting systemic therapy.
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I may or may not have started taking bisphosphonates.
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I have used treatments for cancer spread to bones, fitting the study's treatment plan.
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I am mostly able to care for myself and carry out daily activities.
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I have had chemotherapy for my initial breast cancer.
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My doctor believes my tumor can be safely treated with high-dose radiation.
Select...
My liver and kidney functions are within safe ranges.
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I have 1 to 3 areas of cancer spread in my bones.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Patients with Progression-Free Survival (PFS)
Side effects data
From 2012 Phase 4 trial • 44 Patients • NCT0112933647%
Constipation
33%
Nausea
33%
Neutropenia
27%
Fatigue
27%
Dyspnoea
27%
Vomiting
27%
Diarrhoea
20%
Arthralgia
20%
Oedema peripheral
20%
Myalgia
20%
Neuropathy peripheral
13%
Upper respiratory tract infection
13%
Urinary tract infection
13%
Bone pain
13%
Asthenia
13%
Mucosal inflammation
13%
Cough
13%
Thrombocytopenia
13%
Abdominal pain
13%
Nasopharyngitis
13%
Hypokalaemia
13%
Insomnia
13%
Nasal congestion
13%
Night sweats
13%
Hot flush
7%
Rash
7%
Urine output decreased
7%
Postoperative wound infection
7%
Sinus headache
7%
Hypocalcaemia
7%
Radiation skin injury
7%
Back pain
7%
Tremor
7%
Sleep disorder
7%
Productive cough
7%
Abdominal pain upper
7%
Dysphagia
7%
Anaemia
7%
Vulvovaginal candidiasis
7%
Alopecia
7%
Drug hypersensitivity
7%
Palpitations
7%
Stomatitis
7%
Weight increased
7%
Haemoglobin decreased
7%
Dehydration
7%
Oedema mouth
7%
Rectal haemorrhage
7%
Hyponatraemia
7%
Coagulopathy
7%
Abdominal distension
7%
Leukopenia
7%
Generalised oedema
7%
Deafness
7%
Lip ulceration
7%
Erythema of eyelid
7%
Abdominal discomfort
7%
Chest pain
7%
Jaundice
7%
Acute sinusitis
7%
Cellulitis
7%
Hypoalbuminaemia
7%
Platelet count decreased
7%
Hypochloraemia
7%
Musculoskeletal pain
7%
Pain in jaw
7%
Dizziness
7%
Bladder irritation
7%
Muscular weakness
7%
Headache
7%
Pain in extremity
7%
Wheezing
7%
Joint swelling
7%
Dyspnoea paroxysmal nocturnal
7%
Musculoskeletal chest pain
7%
Dysphonia
7%
Dermatitis contact
7%
Orthopnoea
7%
Dysgeusia
7%
Depression
7%
Oropharyngeal pain
7%
Hyperhidrosis
7%
Palmar-plantar erythrodysaesthesia syndrome
7%
Plantar erythema
7%
Lymphoedema
7%
Skin exfoliation
7%
Hypertension
7%
Flushing
100%
80%
60%
40%
20%
0%
Study treatment Arm
Patients Without Bone Metastases
Patients With Bone Metastases
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
2,958 Previous Clinical Trials
1,798,317 Total Patients Enrolled
147 Trials studying Breast Cancer
63,251 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA granted approval to Standard Therapy?
"Based on existing clinical data, Standard Therapy has been assigned a safety rating of 2. This is due to there being sufficient proof of its security but no evidence thus far that it can produce the desired results in patients."
Answered by AI
Are there still opportunities for participants to join this experiment?
"Information on clinicaltrials.gov reveals that this medical experiment is not presently seeking patients, having been last updated in October 11th 2022. Despite being closed to recruitment, there are 3178 other studies with active search for participants."
Answered by AI
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