Stage IIA Breast CancerNCT01897441
Chemotherapy Before Surgery and Tissue Sample Collection in Patients With Stage IIA-IIIC Breast Cancer
A study testing Cyclophosphamide, Cytology Specimen Collection Procedure and Doxorubicin Hydrochloride in people with Stage IIA Breast Cancer and Stage IIB Breast Cancer, run by Albert Einstein College of Medicine at 1 site in United States.
Trial summary
This pilot clinical trial studies chemotherapy before surgery and tissue sample collection in patients with stage IIA-IIIC breast cancer. Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage IIA Breast Cancer, Stage IIB Breast Cancer, Stage IIIA Breast Cancer
- What is being tested?
- Cyclophosphamide, Cytology Specimen Collection Procedure and Doxorubicin Hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to 25 Oct 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histologically confirmed adenocarcinoma of the breast associated with the following clinical stage: IIA, IIB, IIIA, IIIB, or IIIC; patients with stage IV disease are also eligible if there is an intention to perform breast surgery after neoadjuvant therapy is completed, or in patients participating in clinical trials where surgery after neoadjuvant therapy may be an option (eg. E2108)
- Estrogen receptor (ER), progesterone receptor (PR), and HER2/neu status documented by core needle biopsy of the primary tumor and/or regional lymph node must be known prior to beginning systemic therapy
- Patients must have had a bilateral diagnostic mammogram within 6 months of registration, and may also have a targeted sonography of the breast and/or ipsilateral axilla and magnetic resonance imaging (MRI) if clinically indicated
- Patients with clinically suspicious axillary lymph node involvement must have either aspiration cytology or biopsy prior to beginning therapy
- It is strongly encouraged that all patients have metallic clips placed in the tumor prior to neoadjuvant therapy in order to facilitate evaluation for microscopic disease at the time of surgery; placement of clips is particularly encouraged for patients being considered for breast conserving surgery
- No prior chemotherapy, irradiation, or definitive therapeutic surgery (eg, mastectomy or lumpectomy or axillary dissection) for this malignancy; patients who have had a prior sentinel lymph node biopsy for this malignancy are eligible
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- Patients who received tamoxifen or another selective estrogen receptor modulator (SERM) for prevention or for other indications (e.g., osteoporosis, prior ductal carcinoma in situ [DCIS]) are eligible; tamoxifen therapy or other SERMs should be discontinued at least 1 week before the patient is enrolled on this study
- The patient is medically suitable candidate for preoperative chemotherapy and surgery in the judgment of the treating physicians
- Ability to understand and the willingness to sign a written informed consent document, and willing to provide blood samples before and during preoperative therapy; patients are also asked but not required to have research biopsies performed before and after therapy
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Albert Einstein College of Medicine
The Bronx, New York, 10461
About this study
Official title: Prospective Tissue Collection in Breast Cancer Patients Receiving Preoperative Systemic Therapy
This pilot clinical trial studies chemotherapy before surgery and tissue sample collection in patients with stage IIA-IIIC breast cancer. Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, may interfere with the ability of tumor cells to grow and spread. Giving doxorubicin hydrochloride, cyclophosphamide, paclitaxel and trastuzumab may kill more tumor cells. Collecting and storing samples of tissue from patients with breast cancer to study in the laboratory may help doctors learn more about how well patients will respond to treatment.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the effects of preoperative neoadjuvant paclitaxel and doxorubicin (doxorubicin hydrochloride)/cyclophosphamide (AC) on: senescence; invasion/motility (tumor microenvironment of metastasis [TMEM] and 67 kDa laminin receptor [67LR]).
II. To create a biospecimen repository for future studies derived from patients with breast cancer receiving standard neoadjuvant chemotherapy.
OUTLINE: Patients with human epidermal growth factor receptor 2 (HER2)-positive disease are assigned to Stratum A, and patients with HER2-negative disease are randomized to Stratum B or C.
STRATUM A: Patients receive paclitaxel intravenously (IV) over 1 hour and trastuzumab IV over 30-90 minutes weekly for 12 weeks. Beginning 2-3 weeks later, patients receive doxorubicin hydrochloride IV over 5-10 minutes and cyclophosphamide IV over 30-60 minutes every 2 weeks for 8 weeks
STRATUM B: Patients receive paclitaxel, doxorubicin hydrochloride, and cyclophosphamide as in Stratum A.
STRATUM C: Patients receive doxorubicin hydrochloride IV over 5-10 minutes and cyclophosphamide IV over 30-60 minutes every 2 weeks for 8 weeks. Patients then receive paclitaxel IV over 1 hour weekly for 12 weeks.
Patients undergo surgery 2-6 weeks after the last chemotherapy dose.
In all arms, treatment continues in the absence of unacceptable toxicity.
- Conditions
- Stage IIA Breast Cancer, Stage IIB Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Stage IV Breast Cancer
- Being tested
- Cyclophosphamide, Cytology Specimen Collection Procedure, Doxorubicin Hydrochloride, Laboratory Biomarker Analysis, Paclitaxel
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclophosphamideDrug
Also called (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Carloxan, Ciclofosfamida
Given IV
Cytology Specimen Collection ProcedureOther
Also called Cytologic Sampling
Correlative studies
Also called 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI), ADM, Adriacin, Adriamycin
Given IV
Laboratory Biomarker AnalysisOther
Correlative studies
PaclitaxelDrug
Also called Anzatax, Asotax, Bristaxol, Praxel
Given IV
TrastuzumabBiological
Also called ABP 980, Anti-c-ERB-2, Anti-c-erbB2 Monoclonal Antibody, Anti-ERB-2
Given IV
Endocrine therapyDrug
Also called Arimidex (anastrozole), Femara (letrozole), Aromasin (exemestane), Nolvadex (tamoxifen)
Patients with ER-positive, HER2-negative disease may receive neoadjuvant endocrine therapy (NET) with an aromatase inhibitor: (either Anastrozole 1 mg po daily; Letrozole 2.5 mg po daily, Exemestane 25 mg po daily or Tamoxifen 20 mg po daily) for 4-6 months prior to surgery (or longer if clinically indicated). Anastrozole for 6 months is the preferred regimen for NET.
| Study group | Role | What they receive |
|---|---|---|
| Stratum A: HER2-positive | Experimental | Patients receive Paclitaxel 80 mg/m^2 IV infusion over 1 hour for 12 weeks and Trastuzumab 8 mg/kg IV loading dose over 90 minutes, then 6 mg/kg IV every three weeks (after Paclitaxel when given concurrently) for a total of 17 doses over 51 weeks. Beginning 2-3 weeks after the last dose of Paclitaxel, patients receive Doxorubicin hydrochloride 60 mg/m^2 IV over 5-10 minutes and Cyclophosphamide 600 mg/m^2 IV infusion over 30-60 minutes every 2 weeks for 8 weeks. Receives: Drug: Cyclophosphamide; Other: Cytology Specimen Collection Procedure; Drug: Doxorubicin Hydrochloride; Other: Laboratory Biomarker Analysis; Drug: Paclitaxel; Biological: Trastuzumab |
| Stratum B: HER2-negative | Experimental | Patients receive sequential Paclitaxel followed by Doxorubicin hydrochloride and Cyclophosphamide (AC) as described in Stratum A. Receives: Drug: Cyclophosphamide; Other: Cytology Specimen Collection Procedure; Drug: Doxorubicin Hydrochloride; Other: Laboratory Biomarker Analysis; Drug: Paclitaxel |
| Stratum C: HER2-negative | Experimental | Patients receive sequential Doxorubicin hydrochloride and Cyclophosphamide (AC) followed by Paclitaxel. Patients receive Doxorubicin hydrochloride IV over 5-10 minutes and cyclophosphamide IV over 30-60 minutes every 2 weeks for 8 weeks. Patients then receive paclitaxel IV over 1 hour weekly for 12 weeks. Receives: Drug: Cyclophosphamide; Other: Cytology Specimen Collection Procedure; Drug: Doxorubicin Hydrochloride; Other: Laboratory Biomarker Analysis; Drug: Paclitaxel |
| Stratum I: HER2-negative | Experimental | Patients receive Paclitaxel 80 mg/m^2 IV infusion over 1 hour for 12 weeks followed by Doxorubicin hydrochloride and Cyclophosphamide (AC). Patients receive Doxorubicin hydrochloride 60 mg/m^2 IV over 5-10 minutes and Cyclophosphamide 600 mg/m^2 IV infusion over 30-60 minutes every 2 weeks for 8 weeks. Receives: Drug: Cyclophosphamide; Other: Cytology Specimen Collection Procedure; Drug: Doxorubicin Hydrochloride; Other: Laboratory Biomarker Analysis; Drug: Paclitaxel |
| Stratum II: HER2-positive | Experimental | Patients receive Paclitaxel 80 mg/m^2 IV infusion over 1 hour for 12 weeks and Trastuzumab 8 mg/kg IV loading dose over 90 minutes, then 6 mg/kg IV every three weeks (after Paclitaxel when given concurrently) for a total of 17 doses over 51 weeks. Beginning 2-3 weeks after the last dose of Paclitaxel, patients receive Doxorubicin hydrochloride 60 mg/m^2 IV over 5-10 minutes and Cyclophosphamide 600 mg/m^2 IV infusion over 30-60 minutes every 2 weeks for 8 weeks. Receives: Drug: Cyclophosphamide; Other: Cytology Specimen Collection Procedure; Drug: Doxorubicin Hydrochloride; Other: Laboratory Biomarker Analysis; Drug: Paclitaxel; Biological: Trastuzumab |
| Stratum III: ER2-positive, HER2-negative | Experimental | Patients with ER-positive, HER2-negative disease may receive neoadjuvant endocrine therapy (NET) with an aromatase inhibitor: (either Anastrozole 1 mg po daily; Letrozole 2.5 mg po daily, Exemestane 25 mg po daily or Tamoxifen 20 mg po daily) for 4-6 months prior to surgery (or longer if clinically indicated). Anastrozole for 6 months is the preferred regimen for NET. Receives: Other: Cytology Specimen Collection Procedure; Other: Laboratory Biomarker Analysis; Drug: Endocrine therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Senescence and Secondary Biomarkers, Including TMEM, Mena, and 67LR
Descriptive statistics by treatment group will be presented. The two-sampled t-test will be performed. Appropriate transformation may be used to improve normality of the outcome variable.
Measured: Baseline to 6 months
Secondary outcomes (1)
Changes in Quantitative Biomarker Levels in Patients With Chemotherapy-responsive and -Resistant Tumors, Including Senescence, Cell Death, TMEM, Mena, and 67LR
Paired T-test or Wilcoxon signed-rank test will be performed. Two-sample t-test will be performed to compare biomarker between the two groups. If the data are not normally distributed, a suitable data transformation such as the log or rank transformation will be applied. Logistic regression models will also be fit to the data with treatment sensitive/resistance category as the outcome and baseline as well as pre-post change in biomarker level as the main predictor variable to obtain estimates of odds ratios unadjusted and adjusted for potential confounders including patients characteristics.
Measured: Baseline to 8 weeks (2 courses)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2013 (estimated)
- Study startJun 2013
- Primary completion25 Oct 2023
- Study completion25 Oct 2023
Why it stopped: Interventional component of study terminated prior to full enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stage IIA Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jesus Anampa, MD, Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01897441
- Sponsor's protocol ID
- 13-02-079
- Other IDs
- NCI-2013-01194, P30CA013330
- Status last verified
- Nov 2024
- First submitted
- 9 Jul 2013
- Last updated
- 24 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Karagiannis GS, Pastoriza JM, Wang Y, Harney AS, Entenberg D, Pignatelli J, Sharma VP, Xue EA, Cheng E, D'Alfonso TM, Jones JG, Anampa J, Rohan TE, Sparano JA, Condeelis JS, Oktay MH. Neoadjuvant chemotherapy induces breast cancer metastasis through a TMEM-mediated mechanism. Sci Transl Med. 2017 Jul 5;9(397):eaan0026. doi: 10.1126/scitranslmed.aan0026.
PubMed 28679654
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Tissue Collection in Breast Cancer Patients Receiving Preoperative Systemic Therapy
- ClinicalTrials.gov ID
- NCT01897441
- Acronym / sponsor ID
- 13-02-079
- Conditions
- Stage IIA Breast Cancer, Stage IIB Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Stage IV Breast Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interventional component of study terminated prior to full enrollment
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2013
- Primary completion
- 25 Oct 2023 (actual)
- Study completion
- 25 Oct 2023 (actual)
- First posted
- 12 Jul 2013 (estimated)
- Results
- Posted 24 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot clinical trial studies chemotherapy before surgery and tissue sample collection in patients with stage IIA-IIIC breast cancer. Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, may interfere with the ability of tumor cells to grow and spread. Giving doxorubicin hydrochloride, cyclophosphamide, paclitaxel and trastuzumab may kill more tumor cells. Collecting and storing samples of tissue from patients with breast cancer to study in the laboratory may help doctors learn more about how well patients will respond to treatment.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate the effects of preoperative neoadjuvant paclitaxel and doxorubicin (doxorubicin hydrochloride)/cyclophosphamide (AC) on: senescence; invasion/motility (tumor microenvironment of metastasis [TMEM] and 67 kDa laminin receptor [67LR]).
II. To create a biospecimen repository for future studies derived from patients with breast cancer receiving standard neoadjuvant chemotherapy.
OUTLINE: Patients with human epidermal growth factor receptor 2 (HER2)-positive disease are assigned to Stratum A, and patients with HER2-negative disease are randomized to Stratum B or C.
STRATUM A: Patients receive paclitaxel intravenously (IV) over 1 hour and trastuzumab IV over 30-90 minutes weekly for 12 weeks. Beginning 2-3 weeks later, patients receive doxorubicin hydrochloride IV over 5-10 minutes and cyclophosphamide IV over 30-60 minutes every 2 weeks for 8 weeks
STRATUM B: Patients receive paclitaxel, doxorubicin hydrochloride, and cyclophosphamide as in Stratum A.
STRATUM C: Patients receive doxorubicin hydrochloride IV over 5-10 minutes and cyclophosphamide IV over 30-60 minutes every 2 weeks for 8 weeks. Patients then receive paclitaxel IV over 1 hour weekly for 12 weeks.
Patients undergo surgery 2-6 weeks after the last chemotherapy dose.
In all arms, treatment continues in the absence of unacceptable toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Stratum A: HER2-positive | Experimental | Drug: Cyclophosphamide, Other: Cytology Specimen Collection Procedure, Drug: Doxorubicin Hydrochloride, Other: Laboratory Biomarker Analysis, Drug: Paclitaxel, Biological: TrastuzumabPatients receive Paclitaxel 80 mg/m^2 IV infusion over 1 hour for 12 weeks and Trastuzumab 8 mg/kg IV loading dose over 90 minutes, then 6 mg/kg IV every three weeks (after Paclitaxel when given concurrently) for a total of 17 doses over 51 weeks. Beginning 2-3 weeks after the last dose of Paclitaxel, patients receive Doxorubicin hydrochloride 60 mg/m^2 IV over 5-10 minutes and Cyclophosphamide 600 mg/m^2 IV infusion over 30-60 minutes every 2 weeks for 8 weeks. |
| Stratum B: HER2-negative | Experimental | Drug: Cyclophosphamide, Other: Cytology Specimen Collection Procedure, Drug: Doxorubicin Hydrochloride, Other: Laboratory Biomarker Analysis, Drug: PaclitaxelPatients receive sequential Paclitaxel followed by Doxorubicin hydrochloride and Cyclophosphamide (AC) as described in Stratum A. |
| Stratum C: HER2-negative | Experimental | Drug: Cyclophosphamide, Other: Cytology Specimen Collection Procedure, Drug: Doxorubicin Hydrochloride, Other: Laboratory Biomarker Analysis, Drug: PaclitaxelPatients receive sequential Doxorubicin hydrochloride and Cyclophosphamide (AC) followed by Paclitaxel. Patients receive Doxorubicin hydrochloride IV over 5-10 minutes and cyclophosphamide IV over 30-60 minutes every 2 weeks for 8 weeks. Patients then receive paclitaxel IV over 1 hour weekly for 12 weeks. |
| Stratum I: HER2-negative | Experimental | Drug: Cyclophosphamide, Other: Cytology Specimen Collection Procedure, Drug: Doxorubicin Hydrochloride, Other: Laboratory Biomarker Analysis, Drug: PaclitaxelPatients receive Paclitaxel 80 mg/m^2 IV infusion over 1 hour for 12 weeks followed by Doxorubicin hydrochloride and Cyclophosphamide (AC). Patients receive Doxorubicin hydrochloride 60 mg/m^2 IV over 5-10 minutes and Cyclophosphamide 600 mg/m^2 IV infusion over 30-60 minutes every 2 weeks for 8 weeks. |
| Stratum II: HER2-positive | Experimental | Drug: Cyclophosphamide, Other: Cytology Specimen Collection Procedure, Drug: Doxorubicin Hydrochloride, Other: Laboratory Biomarker Analysis, Drug: Paclitaxel, Biological: TrastuzumabPatients receive Paclitaxel 80 mg/m^2 IV infusion over 1 hour for 12 weeks and Trastuzumab 8 mg/kg IV loading dose over 90 minutes, then 6 mg/kg IV every three weeks (after Paclitaxel when given concurrently) for a total of 17 doses over 51 weeks. Beginning 2-3 weeks after the last dose of Paclitaxel, patients receive Doxorubicin hydrochloride 60 mg/m^2 IV over 5-10 minutes and Cyclophosphamide 600 mg/m^2 IV infusion over 30-60 minutes every 2 weeks for 8 weeks. |
| Stratum III: ER2-positive, HER2-negative | Experimental | Other: Cytology Specimen Collection Procedure, Other: Laboratory Biomarker Analysis, Drug: Endocrine therapyPatients with ER-positive, HER2-negative disease may receive neoadjuvant endocrine therapy (NET) with an aromatase inhibitor: (either Anastrozole 1 mg po daily; Letrozole 2.5 mg po daily, Exemestane 25 mg po daily or Tamoxifen 20 mg po daily) for 4-6 months prior to surgery (or longer if clinically indicated). Anastrozole for 6 months is the preferred regimen for NET. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients must have histologically confirmed adenocarcinoma of the breast associated with the following clinical stage: IIA, IIB, IIIA, IIIB, or IIIC; patients with stage IV disease are also eligible if there is an intention to perform breast surgery after neoadjuvant therapy is completed, or in patients participating in clinical trials where surgery after neoadjuvant therapy may be an option (eg. E2108)
- Estrogen receptor (ER), progesterone receptor (PR), and HER2/neu status documented by core needle biopsy of the primary tumor and/or regional lymph node must be known prior to beginning systemic therapy
- Patients must have had a bilateral diagnostic mammogram within 6 months of registration, and may also have a targeted sonography of the breast and/or ipsilateral axilla and magnetic resonance imaging (MRI) if clinically indicated
- Patients with clinically suspicious axillary lymph node involvement must have either aspiration cytology or biopsy prior to beginning therapy
- It is strongly encouraged that all patients have metallic clips placed in the tumor prior to neoadjuvant therapy in order to facilitate evaluation for microscopic disease at the time of surgery; placement of clips is particularly encouraged for patients being considered for breast conserving surgery
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CyclophosphamideAlso: (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Carloxan, CiclofosfamidaGiven IV | Drug | Stratum A: HER2-positive, Stratum B: HER2-negative, Stratum C: HER2-negative, Stratum I: HER2-negative, Stratum II: HER2-positive |
| Cytology Specimen Collection ProcedureAlso: Cytologic SamplingCorrelative studies | Other | Stratum A: HER2-positive, Stratum B: HER2-negative, Stratum C: HER2-negative, Stratum I: HER2-negative, Stratum II: HER2-positive, Stratum III: ER2-positive, HER2-negative |
| Doxorubicin HydrochlorideAlso: 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI), ADM, Adriacin, AdriamycinGiven IV | Drug | Stratum A: HER2-positive, Stratum B: HER2-negative, Stratum C: HER2-negative, Stratum I: HER2-negative, Stratum II: HER2-positive |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Stratum A: HER2-positive, Stratum B: HER2-negative, Stratum C: HER2-negative, Stratum I: HER2-negative, Stratum II: HER2-positive, Stratum III: ER2-positive, HER2-negative |
| PaclitaxelAlso: Anzatax, Asotax, Bristaxol, PraxelGiven IV | Drug | Stratum A: HER2-positive, Stratum B: HER2-negative, Stratum C: HER2-negative, Stratum I: HER2-negative, Stratum II: HER2-positive |
| TrastuzumabAlso: ABP 980, Anti-c-ERB-2, Anti-c-erbB2 Monoclonal Antibody, Anti-ERB-2Given IV | Biological | Stratum A: HER2-positive, Stratum II: HER2-positive |
| Endocrine therapyAlso: Arimidex (anastrozole), Femara (letrozole), Aromasin (exemestane), Nolvadex (tamoxifen)Patients with ER-positive, HER2-negative disease may receive neoadjuvant endocrine therapy (NET) with an aromatase inhibitor: (either Anastrozole 1 mg po daily; Letrozole 2.5 mg po daily, Exemestane 25 mg po daily or Tamoxifen 20 mg po daily) for 4-6 months prior to surgery (or longer if clinically indicated). Anastrozole for 6 months is the preferred regimen for NET. | Drug | Stratum III: ER2-positive, HER2-negative |
Primary outcome
Changes in Senescence and Secondary Biomarkers, Including TMEM, Mena, and 67LR
Time frame: Baseline to 6 months
Descriptive statistics by treatment group will be presented. The two-sampled t-test will be performed. Appropriate transformation may be used to improve normality of the outcome variable.
1 secondary outcome
Changes in Quantitative Biomarker Levels in Patients With Chemotherapy-responsive and -Resistant Tumors, Including Senescence, Cell Death, TMEM, Mena, and 67LR
Time frame: Baseline to 8 weeks (2 courses)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28679654Karagiannis GS, Pastoriza JM, Wang Y, Harney AS, Entenberg D, Pignatelli J, Sharma VP, Xue EA, Cheng E, D'Alfonso TM, Jones JG, Anampa J, Rohan TE, Sparano JA, Condeelis JS, Oktay MH. Neoadjuvant chemotherapy induces breast cancer metastasis through a TMEM-mediated mechanism. Sci Transl Med. 2017 Jul 5;9(397):eaan0026. doi: 10.1126/scitranslmed.aan0026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jesus Anampa, MD principal investigator
Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cyclophosphamide, Cytology Specimen Collection Procedure and Doxorubicin Hydrochloride in people with Stage IIA Breast Cancer and Stage IIB Breast Cancer, run by Albert Einstein College of Medicine at 1 site 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 9 inclusion and 0 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: stopped early, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Changes in Senescence and Secondary Biomarkers, Including TMEM, Mena, and 67LR (time frame: Baseline to 6 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 NCT01897441, which also lists 1 linked publication.
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 24 Dec 2024.