Aggressive Local Therapy for Breast Cancer

Age: Any Age

Sex: Female

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Organ metastasis, Scleroderma, Lupus, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

35 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical research study is to find out if adding local therapy (surgery and/or radiation) to standard therapy (chemotherapy or endocrine therapy) in the treatment of patients with metastatic breast cancer can help to control the disease for a longer period of time than standard therapy alone.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it mentions that previous use of systemic therapy for bone metastasis is allowed if it fits within the treatment plan.

What data supports the effectiveness of the treatment Local Therapy, Standard Therapy for breast cancer?

Research shows that combining local treatments like surgery and radiation with systemic therapies (treatments that affect the whole body) can improve survival rates and control the spread of breast cancer. Multimodality strategies, which use a combination of treatments, have been effective in managing locally advanced breast cancer, leading to long-term local control and increased survival rates. ^{1 2 3 4 5}

Is aggressive local therapy for breast cancer safe for humans?

The research articles reviewed do not provide specific safety data for aggressive local therapy for breast cancer. However, they discuss adverse events related to cancer treatments in general, indicating that side effects are common and can vary in severity. ^{6 7 8 9 10}

How does the treatment 'Standard Therapy' for aggressive local therapy in breast cancer differ from other treatments?

Standard Therapy for aggressive local therapy in breast cancer typically involves a combination of treatments, including primary chemotherapy to shrink the tumor, followed by surgery and/or radiation to remove or destroy remaining cancer cells. This approach is unique because it allows for breast conservation in many cases and has been shown to improve survival rates, especially in locally advanced breast cancer, compared to using surgery or radiation alone. ^{1 3 11 12 13}

Research Team

Eric A. Strom

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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.

Inclusion 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.

Exclusion Criteria

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.

Central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant to preclude informed consent or interfere with complying with protocol treatments

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Standard Therapy

Participants receive 3 to 9 months of systemic therapy, including chemotherapy or endocrine therapy, as decided by their doctor

3-9 months

Regular visits as per treatment protocol

Local Therapy

Participants receive local treatments including high-dose radiation therapy and/or surgery for bone metastases

6-8 weeks for radiation, 4-6 weeks for surgery

Daily visits for radiation therapy, surgery as needed

Follow-up

Participants are monitored for safety and effectiveness after treatment with periodic imaging and tests

36 months

Every 3 months for the first year, then every 6 months for the next 2 years

Treatment Details

Interventions

• Local Therapy
• Standard Therapy

Trial Overview 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.

Participant Groups

Group I: Standard Therapy + Local Therapy Experimental Treatment 2 Interventions

Systemic Standard Therapy (chemotherapy and/or endocrine therapy) + Local Therapy (surgery and/or radiation)

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Findings from Research

A virtual interdisciplinary communication workshop was found to be feasible and acceptable for improving communication among oncology team members, based on feedback from 87 patients and 56 clinicians.

The workshop highlighted areas for improvement in communication practices, suggesting that targeted interventions can enhance patient care and safety in ambulatory oncology settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Evaluation of a Data-Driven, Interactive Workshop to Facilitate Communication and Teamwork in Ambulatory Medical Oncology Settings. Blok, AC., Costa, DK., Wright, NC., et al.[2023]

In a study of 1,551 patients with metastatic breast cancer, the most common chemotherapy-related complications were anemia (50.7%), bilirubin elevation (26.4%), and leukopenia (24.8%), highlighting significant safety concerns associated with treatment.

The economic impact of these adverse events was substantial, with average monthly healthcare costs increasing significantly—by $854 to $5,320—depending on the treatment cohort and the number of adverse events experienced.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigation of adverse-event-related costs for patients with metastatic breast cancer in a real-world setting. Hurvitz, S., Guerin, A., Brammer, M., et al.[2021]

In a study of 331 breast cancer patients undergoing adjuvant radiotherapy, 75% reported at least one patient-reported outcome (PRO) grade ≥2, indicating significant side effects, while 28% reported grade ≥3, which reflects more severe adverse effects.

Patients receiving hypofractionated (HF) radiotherapy had a significantly lower risk of experiencing severe side effects (PRO-CTCAE grade ≥3) compared to those receiving conventional fractionation (CF), suggesting that HF may be a safer option for minimizing treatment-related toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported outcomes for patients with breast cancer undergoing radiotherapy: A single-center registry experience. Laughlin, BS., Bhangoo, RS., Thorpe, CS., et al.[2022]

In a study of 15,443 women with metastatic breast cancer, those experiencing treatment-related adverse events (AEs) had significantly higher monthly healthcare costs, with taxane treatments costing an additional $1,142 and capecitabine $1,817 in first-line therapy.

The costs associated with AEs increased further in second-line therapy, particularly for capecitabine, which had an incremental cost of $4,437, highlighting the economic burden of AEs and suggesting that choosing treatments with fewer AEs could lead to better financial and health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification and cost of adverse events in metastatic breast cancer in taxane and capecitabine based regimens. Hansen, RN., Ramsey, SD., Lalla, D., et al.[2021]

Combined modality therapy, which includes primary chemotherapy followed by surgery or radiation, is the preferred treatment for locally advanced breast cancer, leading to significant tumor size reduction in over 50% of cases and down-staging in about 70% of patients.

This approach has dramatically improved outcomes for patients with inflammatory breast cancer, transforming it from a fatal condition to one with 5-year survival rates of 35-60%, and potentially one-third of patients surviving beyond 10 years without recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multidisciplinary management of advanced primary and metastatic breast cancer. Hortobagyi, GN.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Management of patients with locally advanced breast cancer. [2022]

2. Ireland pubmed.ncbi.nlm.nih.gov

Breast radiotherapy as part of loco-regional treatments in stage IV breast cancer patients with oligometastatic disease. [2010]

3. England pubmed.ncbi.nlm.nih.gov

Locally Advanced Breast Cancer. [2019]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Tailoring therapy for locally advanced breast cancer using molecular profiles: are we there yet? [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Stage III breast cancer: is neoadjuvant chemotherapy always necessary? [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Grading dermatologic adverse events of cancer treatments: the Common Terminology Criteria for Adverse Events Version 4.0. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Development and Evaluation of a Data-Driven, Interactive Workshop to Facilitate Communication and Teamwork in Ambulatory Medical Oncology Settings. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Investigation of adverse-event-related costs for patients with metastatic breast cancer in a real-world setting. [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Patient-reported outcomes for patients with breast cancer undergoing radiotherapy: A single-center registry experience. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Identification and cost of adverse events in metastatic breast cancer in taxane and capecitabine based regimens. [2021]

11. France pubmed.ncbi.nlm.nih.gov

[Role of radiotherapy in the management of adenocarcinoma of the breast accessible to conservative surgery]. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Multidisciplinary management of advanced primary and metastatic breast cancer. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Primary treatment for breast cancer. [2019]