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'ADVANCE' (A Pilot Trial)

Primary Purpose

Breast Cancer

Status

Active

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Paclitaxel

Cyclophosphamide

Carboplatin

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Breast Cancer

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

City of Hope National Medical Center
Brigham and Women's Hospital
Dana Farber Cancer Institute
Dana-Farber/Brigham and Women's Cancer Center (DF/BWCC) at Milford Regional Medical Center
Dana-Farber/Brigham and Women's Cancer Center (DF/BWCC) in Clinical Affiliation with South Shore Hospital
Novant Health Oncology Specialists

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Carboplatin + Paclitaxel

Cyclophosphamide + Paclitaxel

Arm Description

Paclitaxel will be administered intravenously 3 times per cycle Carboplatin will be administered intravenously 3 times per cycle

Paclitaxel will be administered intravenously 3 times per cycle Cyclophosphamide will be administered once per cycle

Outcomes

Primary Outcome Measures

Toxicity and receipt of planned therapy (feasibility)

Examine the number of treatments received divided by the denominator of 12 treatments

Secondary Outcome Measures

Adverse events

Using CTCAE standard reporting

NCI PRO-CTCAE

Examine patient reported CTCAEs on study treatment and their agreement with provider reports.

Consequences of toxicity or disease events

Frequency of hospitalizations, deaths, emergency room visits

Invasive disease-free survival

recurrences and survival as per STEEP definitions and whether recurrences are local or distant

Overall survival

We will examine the time from study registration to death

Full Information

NCT ID

NCT03858322

First Posted

February 25, 2019

Last Updated

July 3, 2023

Sponsor

Dana-Farber Cancer Institute

Collaborators

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT03858322

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

March 21, 2019 (Actual)

Primary Completion Date

November 10, 2020 (Actual)

Study Completion Date

December 21, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Dana-Farber Cancer Institute

Collaborators

Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

Breast Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

41 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Carboplatin + Paclitaxel

Arm Type

Experimental

Arm Description

Paclitaxel will be administered intravenously 3 times per cycle Carboplatin will be administered intravenously 3 times per cycle

Arm Title

Cyclophosphamide + Paclitaxel

Arm Type

Experimental

Arm Description

Paclitaxel will be administered intravenously 3 times per cycle Cyclophosphamide will be administered once per cycle

Intervention Type

Drug

Intervention Name(s)

Paclitaxel

Intervention Description

The drug work by damaging the RNA or DNA that tells the cell how to copy itself in division. If the cells are unable to divide, they die.

Intervention Type

Drug

Intervention Name(s)

Cyclophosphamide

Intervention Description

The drug work by damaging the RNA or DNA that tells the cell how to copy itself in division. If the cells are unable to divide, they die.

Intervention Type

Drug

Intervention Name(s)

Carboplatin

Intervention Description

The drug work by damaging the RNA or DNA that tells the cell how to copy itself in division. If the cells are unable to divide, they die.

Primary Outcome Measure Information:

Title

Toxicity and receipt of planned therapy (feasibility)

Description

Examine the number of treatments received divided by the denominator of 12 treatments

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Adverse events

Description

Using CTCAE standard reporting

Time Frame

2 years

Title

NCI PRO-CTCAE

Description

Examine patient reported CTCAEs on study treatment and their agreement with provider reports.

Time Frame

2 Years

Title

Consequences of toxicity or disease events

Description

Frequency of hospitalizations, deaths, emergency room visits

Time Frame

2 years

Title

Invasive disease-free survival

Description

recurrences and survival as per STEEP definitions and whether recurrences are local or distant

Time Frame

2 years

Title

Overall survival

Description

We will examine the time from study registration to death

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rachel Freedman, MD, MPH

Organizational Affiliation

Dana-Farber Cancer Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

City of Hope National Medical Center

City

Duarte

State/Province

California

ZIP/Postal Code

91010

Country

United States

Facility Name

Brigham and Women's Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

Dana Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

Dana-Farber/Brigham and Women's Cancer Center (DF/BWCC) at Milford Regional Medical Center

City

Milford

State/Province

Massachusetts

ZIP/Postal Code

01757

Country

United States

Facility Name

Dana-Farber/Brigham and Women's Cancer Center (DF/BWCC) in Clinical Affiliation with South Shore Hospital

City

South Weymouth

State/Province

Massachusetts

ZIP/Postal Code

02190

Country

United States

Facility Name

Novant Health Oncology Specialists

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research

IPD Sharing Time Frame

Data can be shared no earlier than 1 year following the date of publication

IPD Sharing Access Criteria

BCH - Contact the Technology & Innovation Development Office at www.childrensinnovations.org or email TIDO@childrens.harvard.edu BIDMC - Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu BWH - Contact the Partners Innovations team at http://www.partners.org/innovation DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu MGH - Contact the Partners Innovations team at http://www.partners.org/innovation

Citations:

PubMed Identifier

36163163

Citation

Freedman RA, Li T, Sedrak MS, Hopkins JO, Tayob N, Faggen MG, Sinclair NF, Chen WY, Parsons HA, Mayer EL, Lange PB, Basta AS, Perilla-Glen A, Lederman RI, Wong A, Tiwari A, McAllister SS, Mittendorf EA, Miller PG, Gibson CJ, Burstein HJ. 'ADVANCE' (a pilot trial) ADjuVANt chemotherapy in the elderly: Developing and evaluating lower-toxicity chemotherapy options for older patients with breast cancer. J Geriatr Oncol. 2023 Jan;14(1):101377. doi: 10.1016/j.jgo.2022.09.006. Epub 2022 Sep 23.

Results Reference

derived

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'ADVANCE' (A Pilot Trial)

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