Breast CancerPBICNCT00681993
Trial of Partial Breast Irradiation With Various Concurrent Chemotherapy Regimens
A study testing Standard Dose Dense Doxorubucin and Cyclophosphamide, Standard Doxorubucin and Cyclophosphamide and Standard Docetaxel, Carboplatin, and Herceptin in people with Breast Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
Breast conserving therapy, (BCT), which consists of wide local excision of the tumor followed by 6 weeks of whole breast irradiation, (WBI), is integral to the management of breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Standard Dose Dense Doxorubucin and Cyclophosphamide, Standard Doxorubucin and Cyclophosphamide and Standard Docetaxel, Carboplatin, and Herceptin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to 4 Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Women only
- No healthy volunteers
- Adult, Older adult
Eligibility Criteria:
Each of the criteria in the following section must be met in order for a patient to be considered eligible for registration.
- Patient must be older than 18 years of age
- Patients must have histologically confirmed (by routine H\&E staining) adenocarcinoma of the breast, with the primary tumor < 4 cm and 0 - 3 positive axillary lymph nodes (pathologic T1-2, pathologic N0 -N1, M0). Patients with squamous carcinomas or sarcomas of the breast cancer are NOT eligible.
- Patient must have a history and physical within six weeks prior to the start of any protocol therapy.
- Patient must have had a bilateral mammogram prior to surgery.
- Patients must have undergone a segmental mastectomy (SM) with a level I and ll axillary dissection or sentinel lymph node biopsy. Surgical margins at time of SM must be negative (> or = 2 mm) for both invasive carcinoma and for non-invasive ductal carcinoma. Patients who have post-operative margins which are negative but less than 2mm will be considered eligible if the surgeon states that the margin in question could not be improved.
- Patient must have a Medical Oncology consult and be recommended to receive one of the following regimens: Cyclophosphamide and Doxorubicin (AC); Taxotere, Doxorubicin and Cyclophosphamide (TAC); Taxotere and Cyclophosphamide (TC) or Taxotere, Carboplatin and Trastuzumab (TCH) prior to registration. The use of additional chemotherapy, hormonal therapy or Trastuzumab after the initial regimen is at the discretion of the medical oncologist.
- Patients must be registered such that radiation therapy begins no sooner than 7 days prior to, but no later than 7 days after, day 1 of cycle 1 (C1D1). Patient must start chemotherapy and radiation less than 14 weeks from the last breast surgical procedure.
- Patients must NOT have received any neo adjuvant chemo or hormonal therapy for the current cancer.
- Patients must have a performance status 0 or 1 by ECOG criteria
- Patients must not have received prior radiation therapy to the involved breast at any time for any reason.
- Any patient with active local-regional disease prior to registration is not eligible.
- No other prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or any other cancer from which the patient has been disease-free for 5 years.
- Patients must not be pregnant due to the potential for fetal harm as a result of this treatment regimen. Women of child-bearing potential must use effective non hormonal contraception while undergoing radiation therapy. Women of child-bearing potential must also have a negative pregnancy test within six weeks prior to start of protocol therapy.
- Patients must not have a serious medical or psychiatric illness which prevents informed consent or compliance with treatment.
- All patients must be informed of the investigational nature of this study and given written informed consent in accordance with institutional and federal guidelines.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231
About this study
Official title: "A Feasibility Trial of Partial Breast Irradiation With Various Concurrent Chemotherapy Regimens (PBIC)"
Breast conserving therapy, (BCT), which consists of wide local excision of the tumor followed by 6 weeks of whole breast irradiation, (WBI), is integral to the management of breast cancer. Evidence now suggests that WBI may not be necessary and treatment to the involved area only, partial breast irradiation, (PBI), may suffice. PBI can be achieved by interstitial or intracavitary brachytherapy, intra-op, or post op external beam radiation therapy. The feasibility, toxicity and efficacy of PBI are currently being studied in both the U.S. and Europe. Review of smaller studies suggests that PBI will prove to be comparable to WBI. Chemotherapy combined with radiation has been shown to increase local control in BCT when compared to radiation alone. However there is little data on how sequencing or timing of these therapies with respect to one another affect outcome. As a result there is no consensus about the optimal combination. There are real and potential benefits to concurrent chemo-radiation therapy. Concurrent therapy 1) allows both treatments to start closer to surgery, theoretically maximizing the benefits of each modality; 2) shortens the overall treatment program; and 3) may also improve local control via chemo-sensitization of residual cancer cells. However, concurrent chemotherapy and WBI have been associated with prohibitive skin toxicity. Since less breast tissue is treated with PBI, this skin toxicity may no longer be prohibitive. We have shown in J0381 that PBI and concurrent dose dense AC is safe. As a follow-up, we propose a phase I/II trial addressing the toxicity and efficacy associated with PBI delivered concurrently with various chemotherapy regimens.
Read the detailed description
- Partial Breast Irradiation with concurrent chemotherapy (various regimens. Subjects will receive Segmental Mastectomy (Lumpectomy)
- Medical Oncology Evaluation
- Consent/Registration Pre-RT evaluation
- Simulation/Treatment Planning
- Chemo-Radiation Therapy: ddAC, Std AC, TAC, TC, TCH or TH Concurrent with PBI - (270 cGy per fraction for 15 fractions). RT may start up to 7days prior to C1D1, but no later than 7 days after C1D1 (+/- 7 days of C1D1 radiation may start)
- Further chemotherapy, hormonal therapy or biologic therapy at the medical oncologist's discretion
- F/U Schedule
- Conditions
- Breast Cancer
- Being tested
- Standard Dose Dense Doxorubucin and Cyclophosphamide, Standard Doxorubucin and Cyclophosphamide, Standard Docetaxel, Carboplatin, and Herceptin, Standard Docetaxel, Doxorubucin and Cyclophosphamide, Standard Docetaxel and Cyclophosphamide
- Keywords
- cosmetic, effect, breast, irradiation, concurrent, chemotherapy, potential acute, late skin, subcutaneous toxicities
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Dose Dense Doxorubucin and CyclophosphamideOther
Also called Doxorubucin (Adriamycin, Rubex, Adriamycin RDF, Adriamycin PFS,, hydroxydaunorubicin, hydroxydaunomycin), Cyclophosphamide (Cytoxan, Neosar, CTX, CPM)
4 cycles of Standard Dose-Dense Doxorubucin and Cyclophosphamide and concurrent radiation therapy at a dose of 270 cGy per fraction for 15 fractions to a total dose of 40.5 Gy. Treatments will be given Monday through Friday for three weeks. Radiation therapy may start 7 days before, but no later than 7 days after, day 1 of cycle 1 of chemotherapy (C1D1).
Standard Doxorubucin and CyclophosphamideOther
Also called Doxorubucin (Adriamycin, Rubex, Adriamycin RDF, Adriamycin PFS,, hydroxydaunorubicin, hydroxydaunomycin), Cyclophosphamide (Cytoxan, Neosar, CTX, CPM)
4 cycles of Standard Dose Doxorubucin and Cyclophosphamide and concurrent radiation therapy at a dose of 270 cGy per fraction for 15 fractions to a total dose of 40.5 Gy. Treatments will be given Monday through Friday for three weeks. Radiation therapy may start 7 days before, but no later than 7 days after, day 1 of cycle 1 of chemotherapy (C1D1).
Standard Docetaxel, Carboplatin, and HerceptinOther
Also called Docetaxel (Taxotere), Carboplatin (CBDCA, Paraplatin, JM-8), Herceptin (Trastuzumab, RhuMAb HER2, HER2/neu, anti-HER2 humanized, monoclonal antibody)
6 cycles of Standard Docetaxel, Carboplatin and Herceptin chemotherapy with concurrent radiation therapy at a dose of 270 cGy per fraction for 15 fractions to a total dose of 40.5 Gy. Treatments will be given Monday through Friday for three weeks. Radiation therapy may start 7 days before, but no later than 7 days after, day 1 of cycle 1 of chemotherapy (C1D1).
Standard Docetaxel, Doxorubucin and CyclophosphamideOther
Also called Docetaxel (Taxotere), Cyclophosphamide (Cytoxan, Neosar, CTX, CPM)
3 cycles of Standard Docetaxel, Doxorubucin and Cyclophosphamide chemotherapy with concurrent radiation therapy at a dose of 270 cGy per fraction for 15 fractions to a total dose of 40.5 Gy. Treatments will be given Monday through Friday for three weeks. Radiation therapy may start 7 days before, but no later than 7 days after, day 1 of cycle 1 of chemotherapy (C1D1).
Standard Docetaxel and CyclophosphamideOther
Also called Docetaxel (Taxotere), Cyclophosphamide (Cytoxan, Neosar, CTX, CPM)
4 cycles of Standard Docetaxel and Cyclophosphamide chemotherapy with concurrent radiation therapy at a dose of 270 cGy per fraction for 15 fractions to a total dose of 40.5 Gy. Treatments will be given Monday through Friday for three weeks. Radiation therapy may start 7 days before, but no later than 7 days after, day 1 of cycle 1 of chemotherapy (C1D1).
| Study group | Role | What they receive |
|---|---|---|
| Standard ddAC chemotherapy with concurrent radiation therapy | Active comparator | Standard dose-dense Adriamycin and Cyclophosphamide (ddAC) chemotherapy and concurrent radiation therapy (RT) Receives: Other: Standard Dose Dense Doxorubucin and Cyclophosphamide |
| Standard AC chemotherapy with concurrent RT | Active comparator | Standard Adriamycin and Cyclophosphamide (AC) chemotherapy and concurrent radiation therapy Receives: Other: Standard Doxorubucin and Cyclophosphamide |
| Standard TCarbo H chemotherapy with concurrent RT | Active comparator | Standard Taxotere, Carboplatin and Herceptin (TCarbo H) chemotherapy and concurrent radiation therapy Receives: Other: Standard Docetaxel, Carboplatin, and Herceptin |
| Standard TAC chemotherapy with concurrent RT | Active comparator | Standard Taxotere, Adriamycin and Cyclophosphamide (TAC) chemotherapy with concurrent radiation therapy Receives: Other: Standard Docetaxel, Doxorubucin and Cyclophosphamide |
| Standard TC chemotherapy with concurrent RT | Active comparator | Standard Taxotere and Cyclophosphamide (TC) chemotherapy with concurrent radiation therapy Receives: Other: Standard Docetaxel and Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute skin toxicities of partial breast irradiation concurrent with chemotherapy (PBIC)
Acute Skin toxicity will be scored on a scale ranging from 0-4, where a higher score reflects more severe toxicity:
0= no change; 1= follicular, fain or dull erythema/epilation/dry/desquamation/decreased swelling; 2= tender or bright erythemal patchy moist desquamation/moderate edema; 3= confluent moist desquamation other than skin folds, pitting edema; 4= ulceration, hemorrhage, necrosis.
Measured: up to 5 years post-intervention
Late skin toxicities of PBIC
Late Skin toxicity will be scored on a scale ranging from 0-4, where a higher score reflects more severe toxicity:
0= none; 1= slight atrophy, pigmentation change, some hair loss; 2= patchy atrophy, moderate telangiectasias, total hair loss; 3= marked atrophy, gross telangiectasias; 4= ulceration
Measured: up to 5 years post-intervention
Subcutaneous tissue toxicities of PBIC
Subcutaneous tissue toxicity will be scored on a scale ranging from 0-4, where a higher score reflects more severe toxicity:
0= none; 1= slight induration (fibrosis) and loss of subcutaneous fat; 2= moderate fibrosis but asymptomatic; slight field contracture; <10% linear reduction; 3= severe induration and loss subcutaneous tissue; field contracture >10% linear reduction; 4= necrosis
Measured: up to 5 years post-intervention
Secondary outcomes (2)
Cosmetic effect of PBIC
Number of participants with Poor, Fair, Good, or Excellent cosmetic effect after PBIC. Cosmetic effect will be graded by the investigator and participant as specified by the grading criteria in the Study Protocol (grading criteria description too large for this field).
Measured: up to 5 years post-intervention
Local control rate of patients treated with PBIC.
Measured: up to 5 years post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2008 (estimated)
- Study startApr 2008
- Primary completionJun 2012
- Study completion4 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Breast Cancer Research Foundation
- Responsible party
- Sponsor
- Investigators
- Richard Zellars, M.D., Principal investigator, The Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsAmit Shah, M.D., Principal investigator, York Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00681993
- Sponsor's protocol ID
- J0805
- Other IDs
- IRB00063221
- Acronym
- PBIC
- Status last verified
- Jan 2019
- First submitted
- 19 May 2008
- Last updated
- 22 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "A Feasibility Trial of Partial Breast Irradiation With Various Concurrent Chemotherapy Regimens (PBIC)"
- ClinicalTrials.gov ID
- NCT00681993
- Acronym / sponsor ID
- PBIC / J0805
- Conditions
- Breast Cancer
- Keywords
- cosmetic, effect, breast, irradiation, concurrent, chemotherapy, potential acute, late skin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Breast Cancer Research Foundation
- Study start
- Apr 2008
- Primary completion
- Jun 2012 (actual)
- Study completion
- 4 Mar 2016 (actual)
- First posted
- 21 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Breast conserving therapy, (BCT), which consists of wide local excision of the tumor followed by 6 weeks of whole breast irradiation, (WBI), is integral to the management of breast cancer. Evidence now suggests that WBI may not be necessary and treatment to the involved area only, partial breast irradiation, (PBI), may suffice. PBI can be achieved by interstitial or intracavitary brachytherapy, intra-op, or post op external beam radiation therapy. The feasibility, toxicity and efficacy of PBI are currently being studied in both the U.S. and Europe. Review of smaller studies suggests that PBI will prove to be comparable to WBI. Chemotherapy combined with radiation has been shown to increase local control in BCT when compared to radiation alone. However there is little data on how sequencing or timing of these therapies with respect to one another affect outcome. As a result there is no consensus about the optimal combination. There are real and potential benefits to concurrent chemo-radiation therapy. Concurrent therapy 1) allows both treatments to start closer to surgery, theoretically maximizing the benefits of each modality; 2) shortens the overall treatment program; and 3) may also improve local control via chemo-sensitization of residual cancer cells. However, concurrent chemotherapy and WBI have been associated with prohibitive skin toxicity. Since less breast tissue is treated with PBI, this skin toxicity may no longer be prohibitive. We have shown in J0381 that PBI and concurrent dose dense AC is safe. As a follow-up, we propose a phase I/II trial addressing the toxicity and efficacy associated with PBI delivered concurrently with various chemotherapy regimens.
Detailed description
- Partial Breast Irradiation with concurrent chemotherapy (various regimens. Subjects will receive Segmental Mastectomy (Lumpectomy)
- Medical Oncology Evaluation
- Consent/Registration Pre-RT evaluation
- Simulation/Treatment Planning
- Chemo-Radiation Therapy: ddAC, Std AC, TAC, TC, TCH or TH Concurrent with PBI - (270 cGy per fraction for 15 fractions). RT may start up to 7days prior to C1D1, but no later than 7 days after C1D1 (+/- 7 days of C1D1 radiation may start)
- Further chemotherapy, hormonal therapy or biologic therapy at the medical oncologist's discretion
- F/U Schedule
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Standard ddAC chemotherapy with concurrent radiation therapy | Active comparator | Other: Standard Dose Dense Doxorubucin and CyclophosphamideStandard dose-dense Adriamycin and Cyclophosphamide (ddAC) chemotherapy and concurrent radiation therapy (RT) |
| Standard AC chemotherapy with concurrent RT | Active comparator | Other: Standard Doxorubucin and CyclophosphamideStandard Adriamycin and Cyclophosphamide (AC) chemotherapy and concurrent radiation therapy |
| Standard TCarbo H chemotherapy with concurrent RT | Active comparator | Other: Standard Docetaxel, Carboplatin, and HerceptinStandard Taxotere, Carboplatin and Herceptin (TCarbo H) chemotherapy and concurrent radiation therapy |
| Standard TAC chemotherapy with concurrent RT | Active comparator | Other: Standard Docetaxel, Doxorubucin and CyclophosphamideStandard Taxotere, Adriamycin and Cyclophosphamide (TAC) chemotherapy with concurrent radiation therapy |
| Standard TC chemotherapy with concurrent RT | Active comparator | Other: Standard Docetaxel and CyclophosphamideStandard Taxotere and Cyclophosphamide (TC) chemotherapy with concurrent radiation therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Standard Dose Dense Doxorubucin and CyclophosphamideAlso: Doxorubucin (Adriamycin, Rubex, Adriamycin RDF, Adriamycin PFS,, hydroxydaunorubicin, hydroxydaunomycin), Cyclophosphamide (Cytoxan, Neosar, CTX, CPM)4 cycles of Standard Dose-Dense Doxorubucin and Cyclophosphamide and concurrent radiation therapy at a dose of 270 cGy per fraction for 15 fractions to a total dose of 40.5 Gy. Treatments will be given Monday through Friday for three weeks. Radiation therapy may start 7 days before, but no later than 7 days after, day 1 of cycle 1 of chemotherapy (C1D1). | Other | Standard ddAC chemotherapy with concurrent radiation therapy |
| Standard Doxorubucin and CyclophosphamideAlso: Doxorubucin (Adriamycin, Rubex, Adriamycin RDF, Adriamycin PFS,, hydroxydaunorubicin, hydroxydaunomycin), Cyclophosphamide (Cytoxan, Neosar, CTX, CPM)4 cycles of Standard Dose Doxorubucin and Cyclophosphamide and concurrent radiation therapy at a dose of 270 cGy per fraction for 15 fractions to a total dose of 40.5 Gy. Treatments will be given Monday through Friday for three weeks. Radiation therapy may start 7 days before, but no later than 7 days after, day 1 of cycle 1 of chemotherapy (C1D1). | Other | Standard AC chemotherapy with concurrent RT |
| Standard Docetaxel, Carboplatin, and HerceptinAlso: Docetaxel (Taxotere), Carboplatin (CBDCA, Paraplatin, JM-8), Herceptin (Trastuzumab, RhuMAb HER2, HER2/neu, anti-HER2 humanized, monoclonal antibody)6 cycles of Standard Docetaxel, Carboplatin and Herceptin chemotherapy with concurrent radiation therapy at a dose of 270 cGy per fraction for 15 fractions to a total dose of 40.5 Gy. Treatments will be given Monday through Friday for three weeks. Radiation therapy may start 7 days before, but no later than 7 days after, day 1 of cycle 1 of chemotherapy (C1D1). | Other | Standard TCarbo H chemotherapy with concurrent RT |
| Standard Docetaxel, Doxorubucin and CyclophosphamideAlso: Docetaxel (Taxotere), Cyclophosphamide (Cytoxan, Neosar, CTX, CPM)3 cycles of Standard Docetaxel, Doxorubucin and Cyclophosphamide chemotherapy with concurrent radiation therapy at a dose of 270 cGy per fraction for 15 fractions to a total dose of 40.5 Gy. Treatments will be given Monday through Friday for three weeks. Radiation therapy may start 7 days before, but no later than 7 days after, day 1 of cycle 1 of chemotherapy (C1D1). | Other | Standard TAC chemotherapy with concurrent RT |
| Standard Docetaxel and CyclophosphamideAlso: Docetaxel (Taxotere), Cyclophosphamide (Cytoxan, Neosar, CTX, CPM)4 cycles of Standard Docetaxel and Cyclophosphamide chemotherapy with concurrent radiation therapy at a dose of 270 cGy per fraction for 15 fractions to a total dose of 40.5 Gy. Treatments will be given Monday through Friday for three weeks. Radiation therapy may start 7 days before, but no later than 7 days after, day 1 of cycle 1 of chemotherapy (C1D1). | Other | Standard TC chemotherapy with concurrent RT |
Primary outcome
Acute skin toxicities of partial breast irradiation concurrent with chemotherapy (PBIC)
Time frame: up to 5 years post-intervention
Acute Skin toxicity will be scored on a scale ranging from 0-4, where a higher score reflects more severe toxicity: 0= no change; 1= follicular, fain or dull erythema/epilation/dry/desquamation/decreased swelling; 2= tender or bright erythemal patchy moist desquamation/moderate edema; 3= confluent moist desquamation other than skin folds, pitting edema; 4= ulceration, hemorrhage, necrosis.
Late skin toxicities of PBIC
Time frame: up to 5 years post-intervention
Late Skin toxicity will be scored on a scale ranging from 0-4, where a higher score reflects more severe toxicity: 0= none; 1= slight atrophy, pigmentation change, some hair loss; 2= patchy atrophy, moderate telangiectasias, total hair loss; 3= marked atrophy, gross telangiectasias; 4= ulceration
Subcutaneous tissue toxicities of PBIC
Time frame: up to 5 years post-intervention
Subcutaneous tissue toxicity will be scored on a scale ranging from 0-4, where a higher score reflects more severe toxicity: 0= none; 1= slight induration (fibrosis) and loss of subcutaneous fat; 2= moderate fibrosis but asymptomatic; slight field contracture; <10% linear reduction; 3= severe induration and loss subcutaneous tissue; field contracture >10% linear reduction; 4= necrosis
2 secondary outcomes
Cosmetic effect of PBIC
Time frame: up to 5 years post-intervention
Local control rate of patients treated with PBIC.
Time frame: up to 5 years post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2019.
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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.
Richard Zellars, M.D. principal investigator
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Amit Shah, M.D. principal investigator
York Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Dose Dense Doxorubucin and Cyclophosphamide, Standard Doxorubucin and Cyclophosphamide and Standard Docetaxel, Carboplatin, and Herceptin in people with Breast Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins 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?
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: finished, as of the sponsor's last update on 22 Jan 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Acute skin toxicities of partial breast irradiation concurrent with chemotherapy (PBIC) (time frame: up to 5 years post-intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jan 2019.