Description:
This study is being conducted to carefully study how chemotherapy is tolerated in group of
patients age 70.
Title
- Brief Title: 'ADVANCE' (A Pilot Trial)
- Official Title: 'ADVANCE' (A Pilot Trial) ADjuVANt Chemotherapy in the Elderly: Developing and Evaluating Lower-Toxicity Chemotherapy Options for Older Patients With Breast Cancer
Clinical Trial IDs
- ORG STUDY ID:
19-031
- NCT ID:
NCT03858322
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| Paclitaxel | | Carboplatin + Paclitaxel |
| Cyclophosphamide | | Cyclophosphamide + Paclitaxel |
| Carboplatin | | Carboplatin + Paclitaxel |
Purpose
This study is being conducted to carefully study how chemotherapy is tolerated in group of
patients age 70.
Detailed Description
This clinical trial is dedicated to patients age 70 and older and is focused on understanding
how the investigators can improve upon breast cancer outcomes for older women, a group of
patients who often do worse than younger patients and who are not well represented in
clinical trials to date. Through this clinical trial, the investigators aim to better
understand the side effects, experiences, and changes in physical function that may occur
with chemotherapy. The investigators are also very interested in the genomics (or
gene-changes) and biological changes that may occur in breast cancers in older women that may
be different from the changes we see in younger patients.
Even though the chemotherapy agents being used in this study are used frequently when
treating breast cancer, The investigators have limited information on how these agents are
tolerated in older patients. This research study is called a Feasibility Study, because the
investigators will be closely monitoring how easily it is to administer chemotherapy to a
relatively small group of participants (up to 40) and to what degree side effects occur. The
investigators will administer commercially available chemotherapy agents used in breast
cancer in the specific setting of the treating older patients with early-stage breast cancer
and with some mild modification of how these agents are given and in what combination.
For participants with triple negative breast cancer, paclitaxel and carboplatin will be
administered in standard, weekly doses. Both agents are FDA-approved for use in early breast
cancer. However, carboplatin and paclitaxel are not typically used as a 'stand-alone'
treatment for breast cancer, meaning they are often used together along with other
chemotherapy agent(s) over a longer period.
For participants with hormone receptor-positive breast cancer, paclitaxel and
cyclophosphamide will be administered, which are both FDA-approved agents to treat breast
cancer as part of a longer regimen to treat early breast cancer. In this clinical trial the
investigators are modifying the way the chemotherapy is delivered so that it may be more
tolerable than the longer treatment course. This clinical trial does not limit the use of
other chemotherapy or other treatments being recommended for breast cancer, but any other
recommended treatments would be given after the participants receive their paclitaxel and
carboplatin on the clinical trial.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Carboplatin + Paclitaxel | Experimental | Paclitaxel will be administered intravenously 3 times per cycle
Carboplatin will be administered intravenously 3 times per cycle | |
| Cyclophosphamide + Paclitaxel | Experimental | Paclitaxel will be administered intravenously 3 times per cycle
Cyclophosphamide will be administered once per cycle | - Paclitaxel
- Cyclophosphamide
|
Eligibility 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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 70 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Toxicity and receipt of planned therapy (feasibility) |
| Time Frame: | 3 months |
| Safety Issue: | |
| Description: | Examine the number of treatments received divided by the denominator of 12 treatments |
Secondary Outcome Measures
| Measure: | Adverse events |
| Time Frame: | 2 years |
| Safety Issue: | |
| Description: | Using CTCAE standard reporting |
| Measure: | NCI PRO-CTCAE |
| Time Frame: | 2 Years |
| Safety Issue: | |
| Description: | Examine patient reported CTCAEs on study treatment and their agreement with provider reports. |
| Measure: | Consequences of toxicity or disease events |
| Time Frame: | 2 years |
| Safety Issue: | |
| Description: | Frequency of hospitalizations, deaths, emergency room visits |
| Measure: | Invasive disease-free survival |
| Time Frame: | 2 years |
| Safety Issue: | |
| Description: | recurrences and survival as per STEEP definitions and whether recurrences are local or distant |
| Measure: | Overall survival |
| Time Frame: | 2 years |
| Safety Issue: | |
| Description: | We will examine the time from study registration to death |
Details
| Phase: | Phase 1 |
| Primary Purpose: | Interventional |
| Overall Status: | Active, not recruiting |
| Lead Sponsor: | Dana-Farber Cancer Institute |
Trial Keywords
Last Updated
July 21, 2021
