Chemotherapy Tolerance in Elderly Patients with Breast Cancer

Not currently recruiting at 5 trial locations

Age: 65+

Sex: Any

Trial Phase: Phase 1

Sponsor: Dana-Farber Cancer Institute

Must not be taking: Investigational agents

Disqualifiers: Prior chemotherapy, Allergic reactions, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how elderly patients with breast cancer respond to specific chemotherapy treatments. Researchers aim to evaluate the effectiveness of two drug combinations: Carboplatin with Paclitaxel and Cyclophosphamide with Paclitaxel, for patients aged 70 and older. The trial targets those with non-metastatic, HER2-negative breast cancer, either hormone receptor-positive or triple-negative. It suits individuals who have not yet received chemotherapy for this cancer and whose doctors recommend initial or follow-up chemotherapy. As a Phase 1 trial, the research focuses on understanding the treatment's effects in people, offering participants the opportunity to be among the first to receive it.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on hormonal therapy, it should be paused during the study treatment.

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

A previous study found that older adults with breast cancer generally tolerated the combination of carboplatin and paclitaxel well. However, older patients often face higher risks for complications. While the treatment is effective, monitoring for side effects is crucial. Another study found that using carboplatin alone in older patients was less practical, suggesting careful consideration for this group.

Research shows that the cyclophosphamide and paclitaxel combination can be safe and effective for breast cancer. However, safety can vary based on administration methods. Older patients might not receive certain types of chemotherapy as often, highlighting the need for careful monitoring.

Overall, both treatment combinations have been used in older adults, but each carries risks. Regular check-ups and communication with healthcare providers are essential to manage side effects effectively. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they explore chemotherapy combinations tailored for elderly breast cancer patients, a group often underrepresented in clinical trials. Unlike the standard of care, which typically involves more aggressive regimens, these combinations aim to balance effectiveness with tolerability. The use of Carboplatin and Cyclophosphamide with Paclitaxel offers potential for reduced side effects while maintaining efficacy. This approach could lead to more personalized and safer treatment options for older adults battling breast cancer.

What evidence suggests that this trial's treatments could be effective for elderly patients with breast cancer?

Research has shown that using carboplatin and paclitaxel together effectively treats breast cancer. One study found this combination worked well for more than half of the patients, with a response rate of 53%. These drugs help shrink tumors, ease symptoms, and slow disease progression. In this trial, some participants will receive the carboplatin and paclitaxel combination.

Similarly, the combination of cyclophosphamide and paclitaxel has shown positive results. Studies indicate that this treatment can be safely administered to women with advanced breast cancer. In this trial, other participants will receive the cyclophosphamide and paclitaxel combination. Patients receiving this combination have experienced longer survival times compared to those on other treatments. Both options have effectively managed breast cancer symptoms and improved patient outcomes. ^{1 6 7 8 9}

Who Is on the Research Team?

Rachel Freedman, MD, MPH

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

This trial is for men and women aged 70 or older with non-metastatic, invasive breast cancer that's HER2-negative. They must be fit enough for chemotherapy, willing to complete surveys, and have not received chemo for the current cancer or certain drugs in the last 2 years.

Inclusion Criteria

Participants must be willing to fill out surveys over time or designate a proxy to answer on their behalf

I know my cancer's estrogen and progesterone receptor status.

My breast cancer has not spread to distant parts of my body.

Exclusion Criteria

I am allergic to medications similar to cyclophosphamide, carboplatin, or paclitaxel.

I have already received chemotherapy for my current cancer.

I am not currently taking any experimental cancer treatments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive chemotherapy with paclitaxel and carboplatin or cyclophosphamide, administered intravenously 3 times per cycle

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adverse events and survival outcomes

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Carboplatin
• Cyclophosphamide
• Paclitaxel

Trial Overview The 'ADVANCE' pilot study tests how well patients age 70 tolerate chemotherapy before or after surgery. It involves Paclitaxel, Cyclophosphamide, and Carboplatin as potential treatments without concurrent surgeries or other therapies.

How Is the Trial Designed?

Group I: Cyclophosphamide + Paclitaxel Experimental Treatment 2 Interventions

* Paclitaxel will be administered intravenously 3 times per cycle * Cyclophosphamide will be administered once per cycle

Group II: Carboplatin + Paclitaxel Experimental Treatment 2 Interventions

* Paclitaxel will be administered intravenously 3 times per cycle * Carboplatin will be administered intravenously 3 times per cycle

Carboplatin is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Paraplatin for:

• Ovarian cancer
• Testicular cancer
• Lung cancer
• Head and neck cancer
• Brain cancer

Approved in European Union as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer

Approved in Canada as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer
• Testicular cancer

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Mayo Clinic

Collaborator

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

In a phase II trial involving 32 elderly patients with untreated advanced non-small cell lung cancer, the combination of weekly nanoparticle albumin-bound-paclitaxel and carboplatin showed a 50% overall response rate and a median overall survival of 17.5 months, indicating significant efficacy.

The treatment was well tolerated, with no treatment-related deaths or febrile neutropenia reported, and it resulted in less neuropathic toxicity compared to traditional regimens, making it a promising option for elderly patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II Study of Modified Carboplatin Plus Weekly Nab-Paclitaxel in Elderly Patients with Non-Small Cell Lung Cancer: North Japan Lung Cancer Study Group Trial 1301. Miyauchi, E., Inoue, A., Usui, K., et al.[2018]

Taxanes, while effective in treating breast cancer, pose greater toxicity risks in older patients, necessitating careful treatment planning to balance efficacy and safety, especially since elderly women are increasingly affected by breast cancer.

In metastatic breast cancer, weekly paclitaxel and three-weekly docetaxel are commonly used with acceptable toxicity, but the standard three-weekly docetaxel dose of 100mg/m² is not suitable for elderly patients, highlighting the need for tailored treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Taxanes in the treatment of breast cancer: Have we better defined their role in older patients? A position paper from a SIOG Task Force. Biganzoli, L., Aapro, M., Loibl, S., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10080267/

'ADVANCE' (A Pilot Trial) ADjuVANt Chemotherapy in the ... Older adults with breast cancer receiving neo/adjuvant chemotherapy are at high risk for poor outcomes and are underrepresented in clinical trials.

2. cancernetwork.com cancernetwork.com/view/paclitaxel-and-carboplatin-first-line-chemotherapy-advanced-breast-cancer

Paclitaxel and Carboplatin as First-Line Chemotherapy for ... The overall response rate of 53% produced by the combination of paclitaxel and carboplatin observed in the present study appears to be higher than that achieved ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT00025688?cond=Breast%20Neoplasms&term=Perez,%20Edith&rank=7

Paclitaxel With or Without Carboplatin in Treating Women ... PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel with or without carboplatin in treating women who have stage IV breast cancer.

4. chemoexperts.com chemoexperts.com/carboplatin-paclitaxel-carbo-taxol-breast-metastatic.html

Treatment Name: Carboplatin + Paclitaxel (Carbo/Taxol®) Carboplatin + paclitaxel is given to shrink tumors, decrease symptoms of breast cancer, and slow the progression of disease.

5. sciencedirect.com sciencedirect.com/science/article/pii/S0923753419368711

Safety and efficacy of weekly nab®-paclitaxel in ... This analysis evaluates safety and efficacy in elderly (≥70 years old) versus younger patients enrolled in a phase III advanced non-small-cell lung cancer ...

6. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2778657

Efficacy and Safety of First-line Single-Agent Carboplatin ... In this randomized clinical trial of 120 vulnerable older patients with ovarian cancer, single-agent carboplatin was less feasible and active than a ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8063137/

Efficacy and Safety of First-line Single-Agent Carboplatin ... This randomized clinical trial compares the feasibility, efficacy, and safety of single-agent carboplatin every 3 weeks, weekly carboplatin–paclitaxel, or ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1879406822002259

'ADVANCE' (a pilot trial) ADjuVANt chemotherapy in the ... Older adults with breast cancer receiving neo/adjuvant chemotherapy are at high risk for poor outcomes and are underrepresented in clinical trials.

9. ascopubs.org ascopubs.org/doi/pdf/10.1200/JCO.2002.08.129

Phase II Multicenter Trial of a Weekly Paclitaxel and ... This study was a first step toward optimizing the schedule for combination paclitaxel and carboplatin therapy in advanced breast cancer. PATIENTS AND METHODS.