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Breast CancerPhase 1NCT03858322

'ADVANCE' (A Pilot Trial)

A Phase 1 study testing Paclitaxel, Cyclophosphamide and Carboplatin in people with Breast Cancer, run by Dana-Farber Cancer Institute at 5 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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

Who is it for?
Ages 70 years and older
Conditions the study is for
Breast Cancer
What is being tested?
Paclitaxel, Cyclophosphamide and Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
5 sitesUnited States
Study dates
21 Mar 2019to 30 Dec 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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
Show all 15Show fewer
  • 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)

Who cannot join

  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

  • City of Hope National Medical Center

    Duarte, California, 91010

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

    Milford, Massachusetts, 01757

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

    South Weymouth, Massachusetts, 02190

  • Novant Health Oncology Specialists

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

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

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

Read the 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.

Conditions
Breast Cancer
Keywords
Breast Cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PaclitaxelDrug

    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.

  • CyclophosphamideDrug

    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.

  • CarboplatinDrug

    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.

Study groups in NCT03858322
Study groupRoleWhat they receive
Carboplatin + PaclitaxelExperimental* Paclitaxel will be administered intravenously 3 times per cycle * Carboplatin will be administered intravenously 3 times per cycle
Receives: Drug: Paclitaxel; Drug: Carboplatin
Cyclophosphamide + PaclitaxelExperimental* Paclitaxel will be administered intravenously 3 times per cycle * Cyclophosphamide will be administered once per cycle
Receives: Drug: Paclitaxel; Drug: Cyclophosphamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Toxicity and receipt of planned therapy (feasibility)

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

    Measured: 3 months

Secondary outcomes (5)

  1. Adverse events

    Using CTCAE standard reporting

    Measured: 2 years

  2. NCI PRO-CTCAE

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

    Measured: 2 Years

  3. Consequences of toxicity or disease events

    Frequency of hospitalizations, deaths, emergency room visits

    Measured: 2 years

  4. Invasive disease-free survival

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

    Measured: 2 years

  5. Overall survival

    We will examine the time from study registration to death

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2019
  2. Study start21 Mar 2019
  3. Primary completion10 Nov 2020
  4. Study completion30 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
41 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03858322
Sponsor's protocol ID
19-031
Status last verified
Aug 2026
First submitted
25 Feb 2019
Last updated
13 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • Mayerhofer C, Sedrak MS, Hopkins JO, Li T, Tayob N, Faggen MG, Sinclair NF, Chen WY, Parsons HA, Mayer EL, Lange PB, Basta AS, Perilla-Glen A, Lederman RI, Wong AR, Tiwari A, McAllister SS, Mittendorf EA, Gibson CJ, Burstein HJ, Kim AS, Freedman RA, Miller PG. Clonal hematopoiesis in older patients with breast cancer receiving chemotherapy. J Natl Cancer Inst. 2023 Aug 8;115(8):981-988. doi: 10.1093/jnci/djad065.

    PubMed 37042724

  • 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.

    PubMed 36163163

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Paclitaxel, Cyclophosphamide and Carboplatin in people with Breast Cancer, run by Dana-Farber Cancer Institute at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Toxicity and receipt of planned therapy (feasibility) (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03858322, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.

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'ADVANCE' (A Pilot Trial) (NCT03858322) | AzTrials