Breast Cancer

For ER negative or ER-low (1+ in 10% of cells or less), IO eligible
T1c and node positive OR T2-4, node positive or negative
Includes inflammatory
No distant metastatic disease
Cannot be planned for adj CDK4/6 inhibitor (ER-low only)

Study evaluating a mindfulness app vs meditation for breast cancer survivors aged 18-51 years. Stage 0-3, completed therapy 6 months to 5 years ago, English or Spanish speakers. May be on endocrine therapy or trastuzumab, but must have completed chemotherapy, CDK4/6 inhibitor, PARP inhibitors, etc. Potential patients are screened with PHQ-8 depression questionaire and then patients with scores between 5-14 are eligible to be randomized to the intervention.
• First-time diagnosis of non-metastatic breast cancer which is Stage 0, I, II, or III.
• a score of ≥ 5 and ≤ 14 on the Patient Health Questionnaire-8 item (PHQ-8)
• completed all primary breast cancer treatments at least 6 months prior to and no more than 5 years prior to registration. Note: Primary treatments include surgery, radiation therapy, adjuvant chemotherapy, and targeted therapies (e.g., PARP inhibitors, CDK4/6 inhibitors, TDM-1, pertuzumab, or immunotherapy). Participants may still be taking adjuvant therapy with trastuzumab or adjuvant endocrine therapy or completing minor reconstructive surgery.

Key Eligibility Criteria:

Inclusion Criteria:
1. Planned intravenous treatment with a minimum of 12 weeks of neurotoxic chemotherapy treatment and with no planned treatment pause for surgery during neurotoxic chemotherapy treatment.
a. With one of the following treatments:
i. Chemotherapy regimens based on Oxaliplatin
1. FOLFOX every 2 weeks
2. FOLFIRINOX every 2 weeks
ii. Chemotherapy regimens based on single-agent Paclitaxel
1. Paclitaxel weekly
2. Paclitaxel every 3 weeks
iii. Chemotherapy regimens based on Paclitaxel + Carboplatin
1. Paclitaxel weekly with Carboplatin weekly/every 3 weeks
2. Paclitaxel every 3 weeks with Carboplatin every 3 weeks
b. Concurrent administration of the chemotherapies listed in the inclusion criteria with or without targeted agents/immunotherapy at standard doses is allowed (such as trastuzumab, pertuzumab, bevacizumab, pembrolizumab or other immune checkpoint inhibitors).
2. Planned taxane or platinum containing portion of chemotherapy regimen prescribed to last at least 12 weeks in duration and less than or equal to 12 months in duration. Note: The regimen is prescribed as per physician discretion in accordance with standard of care guidelines.

Exclusion Criteria:
1. Baseline peripheral neuropathy of any kind as defined by NCI CTCAE v5.0 grade > 0.
2. Any open wounds, sores, cysts or injury on the participant's hand or on part of the upper arm where the device will be applied or on the participant's feet or part of the lower leg where the device will be applied, which in the opinion of the investigator will not be healed prior to infusion commencing or who in the opinion of the investigator will be inappropriate for inclusion in this study.
3. Weight greater than 140 kg at the time of enrollment.
4. Participants who are receiving neuropathy directed systemic therapies at the time of enrollment, namely, Pregabalin, Gabapentin, Amitriptyline, Nortriptyline, Venlafaxine, Duloxetine.

For pre-screening, please contact: Reach out to the disease specific research team.