Chemotherapy Tolerance in Elderly Patients with Breast Cancer

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

41 Participants Needed

Trial Summary

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.

What evidence supports the effectiveness of the drug combination of carboplatin and paclitaxel for elderly patients with breast cancer?

Research shows that carboplatin and paclitaxel are effective and safe for elderly patients with other cancers, like lung cancer, with a good response rate and manageable side effects. Additionally, taxanes, like paclitaxel, are known to be active in treating breast cancer, especially when tailored to the needs of older patients. ^{1 2 3 4 5}

Is chemotherapy with carboplatin and paclitaxel safe for elderly patients?

Research shows that chemotherapy with carboplatin and paclitaxel is generally well tolerated in elderly patients, with some experiencing mild to moderate side effects like fatigue and neuropathy (nerve damage). Serious side effects like severe neutropenia (low white blood cell count) and infection are less common, but they can occur. ^{1 2 3 4 6}

How is the chemotherapy treatment with Carboplatin, Cyclophosphamide, and Paclitaxel different for elderly breast cancer patients?

This treatment is unique because it combines Carboplatin, Cyclophosphamide, and Paclitaxel, which are known to be effective in cancer treatment, but the focus here is on adjusting doses to improve tolerance in elderly patients who often have difficulty with standard chemotherapy due to age-related health issues. ^{1 5 7 8 9}

What is the purpose of this trial?

This study is being conducted to carefully study how chemotherapy is tolerated in group of patients age 70.

Research Team

Rachel Freedman, MD, MPH

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

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 am not currently taking any experimental cancer treatments.

I have already received chemotherapy for my current cancer.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

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

Improved tolerance of primary chemotherapy with reduced-dose carboplatin and paclitaxel in elderly ovarian cancer patients. [2015]

2. Japan pubmed.ncbi.nlm.nih.gov

[A retrospective study of carboplatin and weekly paclitaxel combination chemotherapy for elderly patients with advanced non-small cell lung cancer]. [2015]

3. Ireland pubmed.ncbi.nlm.nih.gov

A phase II study of weekly paclitaxel combined with carboplatin for elderly patients with advanced non-small cell lung cancer. [2015]

4. England 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. [2018]

5. Netherlands 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. [2022]

6. Slovakia pubmed.ncbi.nlm.nih.gov

Weekly paclitaxel for advanced non-small cell lung cancer patients not suitable for platinum-based therapy. [2015]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Nanoparticle Albumin-Bound Paclitaxel in Elderly Patients with Metastatic Breast Cancer: A Meta-Analysis. [2020]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Taxanes in elderly breast cancer patients. [2018]

9. Greece pubmed.ncbi.nlm.nih.gov

Randomized study of dose or schedule modification of granulocyte colony-stimulating factor in platinum-based chemotherapy for elderly patients with lung cancer. [2019]