Clinical Trials /

'ADVANCE' (A Pilot Trial)

NCT03858322

Description:

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

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: 'ADVANCE' (A Pilot Trial) ADjuVANt Chemotherapy in the Elderly: Developing and Evaluating Lower-Toxicity Chemotherapy Options for Older Patients With Breast Cancer
  • 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

  • Breast Cancer

Interventions

DrugSynonymsArms
PaclitaxelCarboplatin + Paclitaxel
CyclophosphamideCyclophosphamide + Paclitaxel
CarboplatinCarboplatin + 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

NameTypeDescriptionInterventions
Carboplatin + PaclitaxelExperimentalPaclitaxel will be administered intravenously 3 times per cycle Carboplatin will be administered intravenously 3 times per cycle
  • Paclitaxel
  • Carboplatin
Cyclophosphamide + PaclitaxelExperimentalPaclitaxel 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:Feasibility for each cohort
Time Frame:3 months
Safety Issue:
Description:Examine the number of treatments received divided by the denominator of 12 treatments

Secondary Outcome Measures

Measure:Changes in geriatric assessment (GA) over time
Time Frame:2 years
Safety Issue:
Description:We will use the GA survey battery to examine changes in functional status and health over time
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:Not yet recruiting
Lead Sponsor:Dana-Farber Cancer Institute

Trial Keywords

  • Breast Cancer

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