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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether adding local therapy, such as surgery or radiation, to standard treatments like chemotherapy or hormone therapy can better control metastatic breast cancer that has spread only to bones. The researchers seek to find out if combining these treatments manages the disease longer than standard therapy alone. Suitable participants have breast cancer that has spread to one to three bone sites but not to other organs. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that adding local treatments like surgery or radiation to standard treatments such as chemotherapy or hormone therapy can be safe for breast cancer patients. One study found that patients who underwent surgery and radiation had a 63.9% chance of surviving breast cancer after three years. This suggests that the treatment can be effective and manageable for some individuals.

However, more extensive surgery might affect quality of life. While the treatment can be safe, it might impact how patients feel during and after treatment. Weighing the benefits and potential downsides is crucial before deciding on any treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the treatment combining standard systemic therapy with aggressive local therapy for breast cancer because it offers a more comprehensive approach. Unlike traditional methods that often focus on either systemic or local treatments separately, this approach integrates chemotherapy and/or endocrine therapy with surgery and/or radiation. The combination aims to target the cancer more effectively by addressing both widespread and localized tumor cells, potentially improving outcomes and reducing recurrence rates. This dual-action strategy could lead to more personalized and effective treatment plans for patients.

What evidence suggests that adding local therapy to standard therapy could be effective for metastatic breast cancer?

Research has shown that aggressive local treatment can extend the lives of patients with breast cancer. One study found that patients who underwent both surgery and radiation had a 3-year survival rate of 63.9% specifically for breast cancer, higher than those who received only surgery or only radiation. In this trial, participants will receive a combination of systemic standard therapy (chemotherapy and/or endocrine therapy) and local therapy (surgery and/or radiation). Another study found that adding radiation after surgery greatly improved survival chances. This suggests that combining local treatments with standard therapies may help control metastatic breast cancer for a longer period. ^{1 6 7 8 9}

Who Is on the Research Team?

Eric A. Strom

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7706410/

Aggressive Local Treatment Improves Survival in Stage IV ...

The 3-year breast cancer-specific survival (BCSS) in patients treated with surgery alone, radiotherapy alone, and surgery+radiotherapy was 57.1, 35.9, and 63.9% ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6382720/

Radiotherapy after surgery has significant survival benefits ...

Our data indicate that radiotherapy after surgery provided significant survival benefits of both BCSS and OS for the TNBC patients. The value of adjuvant ...

3.

ro-journal.biomedcentral.com

ro-journal.biomedcentral.com/articles/10.1186/s13014-023-02357-7

Impact of high dose radiotherapy for breast tumor in ...

With a median follow-up of 17.2 months, the 2-year LC and overall survival (OS) rates were 49.4%, and 48.3%, respectively. Multivariable ...

4.

jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2839036

Adjuvant Radiation and Endocrine Therapy in Early-Stage ...

A number of studies have demonstrated that ODX RS is associated with local outcomes, and several nascent trials seek to employ molecular risk ...

5.

nature.com

nature.com/articles/s41598-019-45016-2

Survival benefit of radiotherapy after surgery in de novo ...

For patients who survived six months or more, radiotherapy after surgery demonstrated favorable prognosis compared to surgery alone (HR 0.593; ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC2924956/

Outcomes following local therapy for early-stage breast ...

We found better survival for BCS with radiation versus mastectomy among older early-stage breast cancer patients, with no difference in survival for BCS with ...

7.

nature.com

nature.com/articles/s41523-025-00744-9

Mapping the current landscape of locoregional therapy de ...

This systematic review demonstrates that the current de-escalation portfolio is inefficient, lacks patient focus and needs improvement.

8.

jamanetwork.com

jamanetwork.com/journals/jamasurgery/fullarticle/2783554

Association of Local Therapy With Quality-of-Life Outcomes ...

These findings suggest that more extensive surgery is associated with poorer quality-of-life outcomes in young breast cancer survivors.

9.

sciencedirect.com

sciencedirect.com/science/article/pii/S0960977623005416

Explaining risks and benefits of loco-regional treatments to ...

In this review, we will focus on the current evidence behind loco-regional breast cancer treatments, and review risks and benefits to help guide patient ...