Overview

'ADVANCE' (A Pilot Trial)

Status:
Active, not recruiting
Trial end date:
2023-03-21
Target enrollment:
0
Participant gender:
All
Summary
This study is being conducted to carefully study how chemotherapy is tolerated in group of patients age 70.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborator:
Mayo Clinic
Treatments:
Albumin-Bound Paclitaxel
Carboplatin
Cyclophosphamide
Paclitaxel
Criteria
Inclusion Criteria:

- Participants must have histologically or cytologically confirmed breast cancer that is
human epidermal growth factor receptor 2 negative (HER2-negative) per the most recent
2018 ASCO CAP guidelines94

- Estrogen Receptor and Progesterone immunohistochemistry (IHC) status must be known;
any status is eligible, but this will define in which cohort a patient will enroll:

- Additional eligibility for cohort 1: Triple negative disease- defined as IHC staining
of <10% for ER and PR per local pathology review

- Additional eligibility for cohort 2: Hormone receptor-positive disease defined as IHC
for ER or PR >/= 10% per local pathology review

- Men and women are eligible

- Age 70 and older at the time of protocol registration

- Non-metastatic, invasive breast cancer (scans are not required to document
non-metastatic disease- any staging work-up is up to the treating provider's
discretion)

- Recommended to have either neoadjuvant chemotherapy or adjuvant chemotherapy per their
treating provider.

- Any surgery, nodal assessment, radiation, hormonal therapy is left up to the treating
provider but should not occur concurrently with study therapy. If any additional
chemotherapy is planned by a treating provider, this must occur AFTER all
study-related chemotherapy is completed.

- Any patient receiving pre-operative hormonal therapy and who is then recommended for
adjuvant chemotherapy is eligible, though hormonal therapy should be held during study
treatment administration

- All study-related chemotherapy must be given prior to surgery if neoadjuvant therapy
is planned or adjuvantly if postoperative chemotherapy is planned. For example, giving
6 doses pre-operatively and 6 doses postoperatively is not allowed on study.

- There are no restrictions on life expectancy, ECOG Performance Status, or baseline
blood values or organ function; Appropriateness of chemotherapy treatment is left up
to the treating provider but providers should be ok with the full starting doses of
each agent.

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

- Ability to understand and the willingness to sign a written informed consent document.

- Patients who do not speak or read English are eligible as long as adequate interpreter
services are available or the surveys are available in the preferred language (i.e.
PRO surveys are available in many languages)

Exclusion Criteria:

- Participants who have already received chemotherapy for the current cancer. Prior
diagnoses of breast cancers are allowed, provided that the treating provider feels
that the current cancer represents a new primary breast cancer and not recurrent
disease.

- Participants who are receiving any other investigational or anti-cancer agents. Any
additional radiation, hormonal therapy or chemotherapy planned should be administered
once the study treatments have completed.

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to cyclophosphamide, carboplatin, and paclitaxel.

- Prior chemotherapy receipt is allowed in the setting of treatment of other/prior
cancers, but no prior carboplatin (cohort 1), cyclophosphamide (cohort 2), or
paclitaxel (both cohorts) receipt in the last 2 years is allowed (given toxicity and
possible efficacy concerns